Z-0378-2018 Class II Terminated

Recalled by Roche Diagnostics Corporation — Indianapolis, IN

FDA device recall Z-0378-2018 was initiated by Roche Diagnostics Corporation on Jun 29, 2017 and is designated Class II. Reason for recall: Roche has confirmed that a possible sample mismatch issue may occur on the MODULAR ANALYTICS E 170 module, cobas e 601 analyzer, or cobas e 602 analyzer due to a software limitation. The recall status is terminated (terminated Jan 24, 2020). Affected quantity: 2517.

Recall Details

Product Type
Devices
Report Date
Jan 24, 2018
Initiation Date
Jun 29, 2017
Termination Date
Jan 24, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2517

Product Description

Brand Name: ¿ cobas c 6000 MODULAR Series System e 601 ¿ cobas c 8000 MODULAR Series System - e 602 ¿ Roche / Hitachi MODULAR Analytics Combination System Model/Catalog/Part Number: MODULAR Analytics E 170 ¿ 03022109001 ¿ 03023109973 ¿ 03739040001 ¿ 03739040692 ¿ 05023572001 ¿ 05023599001 cobas e 601 module ¿ 04745922001 ¿ 04745922692 ¿ 05036348001 ¿ 05036348692 ¿ 05860652001 cobas e 602 module ¿ 05990378001 The Roche/Hitachi MODULAR Analytics System (E170) is a fully automated, random-access, software- controlled system for immunoassay and photometric analysis intended for qualitative and quantitative in vitro determinations using a wide variety of tests. The cobas 6000 series (e 601) is a fully automated, random-access, software-controlled system for immunoassay and photometric analysis intended for qualitative and quantitative in vitro determinations using a wide variety of tests. It is optimized for high throughput workloads in the professional environment using a combination of Ion selective electrodes (ISE), a photometric analysis unit an immunoassay analysis module. The cobas 8000 Modular Analyze Series (e602) is a fully automated system for Clinical chemistry analysis, intended for the in vitro qualitative and quantitative determination of analytes in body fluids. It is optimized for high throughput workloads in the professional environment using a combination of ion selective electrodes (ISE) and a photometric analysis unit.

Reason for Recall

Roche has confirmed that a possible sample mismatch issue may occur on the MODULAR ANALYTICS E 170 module, cobas e 601 analyzer, or cobas e 602 analyzer due to a software limitation.

Distribution Pattern

USA (nationwide) Distribution

Code Information

Serial Number 2072-26 27P6-20 15S2-20 2717-18 2719-02 1544-11 1686-03 1534-12 1698-04 1549-04 2275-12 2263-16 2263-17 2497-16 1849-01 1570-15 26F0-17 2256-18 2564-30 2850-05 2384-12 2384-18 2399-08 2230-19 2230-20 2379-14 2381-02 27Z8-01 2058-22 1909-13 1909-01 27V5-20 15U5-18 2308-01 2087-07 1984-05 1985-07 26D3-30 2497-01 1861-18 1861-19 26D0-27 26D1-21 1480-14 1480-15 1488-01 1488-02 26C3-12 26F0-19 26F0-27 26D9-24 2107-35 2348-12 2348-13 1423-16 2237-18 2240-09 2240-10 16J8-05 16J8-06 16L7-20 16K2-17 16K2-18 16K2-19 16K2-20 16K3-01 16K3-06 16K3-07 16K3-08 16K3-09 16L4-03 16L4-04 26D1-25 26D1-26 26D1-28 26D1-29 2328-03 2437-13 2072-29 2072-30 2064-12 1931-11 2080-35 1936-08 2049-15 27Z0-09 27Z0-10 1911-11 2581-18 2062-14 2074-05 1430-16 1430-17 1691-17 1691-18 1985-13 1989-19 1739-19 2578-25 13B8-12 1169-06 1169-08 1169-09 1211-16 1211-17 1211-18 1224-10 1458-04 2543-10 27J6-15 2048-05 2406-27 26B3-30 1927-19 1914-13 1914-11 27J7-06 2822-07 2822-08 2535-23 2306-04 1159-19 2867-11 2711-02 27Y6-19 2107-20 2195-34 2106-20 2079-34 27M5-13 15D1-02 15C9-10 15F0-17 15F0-18 2137-15 1872-01 2195-40 2102-30 2428-02 2539-08 1377-14 2495-01 1490-16 15C5-16 15C5-17 15C5-20 15C6-01 2250-02 26H6-29 2423-15 2539-06 1377-12 2307-26 2307-27 2227-11 2080-24 1128-05 1128-06 14B1-02 14B2-13 2467-05 27Z8-09 26E4-05 2413-14 2423-19 2086-27 27Z0-14 27Z0-16 2145-16 2321-26 2321-25 26F1-20 26F1-19 1305-40 26G7-23 26G8-09 27L8-12 27X4-14 2719-07 27S8-20 15U1-20 26A4-28 26D1-22 2368-06 1128-19 2427-29 2539-07 1377-13 1357-08 1357-09 1357-10 1344-05 1344-06 14B1-01 1344-02 1344-03 1344-04 1469-03 1469-04 1469-05 1476-20 1482-11 1483-01 1483-17 1483-18 1483-19 1483-20 1484-16 1484-17 1484-18 1490-18 1490-19 1490-20 14A3-01 14A3-02 14A3-03 15B7-01 15B7-02 2430-27 2430-29 15B7-03 2327-25 2347-04 2369-04 2332-04 2332-09 27S4-02 27S4-03 2230-14 2230-18 1211-15 1211-14 15D2-04 15D2-05 15D3-12 15F0-15 15F0-16 16P4-02 16P4-03 2061-21 14A9-16 14A9-17 14A9-18 15B7-04 2256-19 2865-20 2867-01 2070-11 2070-13 2720-17 16X4-17 2102-29 2192-37 2196-02 2535-18 2842-03 2896-04 16P4-04 16P4-07 16P4-08 16P4-09 2311-12 2311-13 1871-09 1125-07 1128-02 2059-28 15H8-11 15H8-12 1996-01 2396-04 2399-06 2068-24 2283-14 2080-02 2577-04 2047-10 2107-05 26E4-10 27J7-04 2585-07 2581-08 2581-13 2327-11 2396-07 2413-01 2413-04 185731 1867-06 2037-07 2423-14 1549-02 27Z8-02 1860-19 2074-25 2087-09 2103-35 1924-15 2192-02 2437-19 2437-20 27Z0-03 2437-17 1913-03 1913-04 2488-05 2402-05 26C3-11 26C9-12 26E4-08 26F3-21 1545-05 1844-14 2822-09 2822-10 1303-31 1303-32 1357-19 1357-20 2402-30 2195-38 2196-01 2080-11 2080-17 2226-17 2439-12 2107-02 1988-03 2086-40 2195-24 2195-06 2195-08 2072-39 2041-12 2047-07 2192-15 2192-08 1736-04 1991-08 1871-06 2037-14 2055-30 2055-35 2873-02 2891-13 1990-05 192506 2894-12 1936-14 1928-19 2848-17 2867-08 2058-21 2058-25 2073-01 2111-04 130833 130834 2850-06 1334-12 1334-13 1334-14 1476-01 1476-02 1476-12 2049-29 2049-30 28E5-14 2347-11 2367-09 27Z8-12 2842-02 192418 1936-09 28A2-10 28AO-16 2208-17 2227-10 15J5-02 15J5-03 1852-15 2256-15 1461-03 1461-04 1476-11 16M7-01 16M7-16 14B3-06 14B3-07 16K3-15 16K3-16 16K3-17 16K3-18 16K3-19 16K3-20 16K4-07 16K4-11 16K4-20 16K5-01 16K5-02 16K5-03 16K5-04 16K5-05 16K5-09 16K5-10 16K7-04 16K7-05 16K7-06 16L4-05 16L4-06 16L4-07 16L4-08 16L7-19 16L5-03 16L7-17 16P1-13 16P1-14 16P1-15 16P2-19 1417-20 2581-25 2587-14 1431-14 2065-12 1545-03 16M7-13 16M8-01 16M8-02 16P1-11 2275-13 2267-19 2275-09 2275-10 2056-14 2047-08 185715 185817 26C3-13 2137-09 15D9-17 15D9-18 2486-24 2489-30 2054-06 2054-10 26E0-18 2467-15 16J8-12 16J8-13 1871-07 2567-22 2367-13 2304-14 2304-15 2202-07 2288-10 1487-16 1488-03 1480-16 1488-04 2427-27 1857-13 2486-06 27J7-03 27Z0-17 27Z0-18 27Z0-19 2494-30 2071-34 2576-22 26E4-06 1124-05 1124-06 1132-03 1132-04 16K5-06 2493-18 2497-12 2848-14 2848-15 2842-01 2848-12 2896-03 2263-13 2263-14 2050-29 2547-29 2550-19 2058-17 2058-20 2054-07 2054-08 2328-05 2439-13 1535-09 2548-03 184826 2497-13 2039-09 2061-35 1905-11 0753-22 1685-16 1570-14 2135-17 2140-11 2493-28 2493-29 2850-09 2850-10 2581-07 2581-22 1867-14 27P6-19 15S2-19 26G7-24 26G7-25 26H3-28 2108-36 192717 2493-23 2494-21 1225-14 2822-20 2824-01 2585-04 1910-02 2540-23 2540-24 1694-19 2104-01 2047-36 0884-01 1991-18 2389-18 2107-29 2108-27 26D6-03 26D5-22 1174-08 2189-02 2189-03 2086-13 2086-21 2446-13 1557-12 2486-23 2867-03 191007 2137-14 16K5-12 16K5-13 16K5-14 16K5-15 2104-02 1725-20 26E4-04 26A9-09 2869-20 16Z2-20 2581-26 2389-13 1142-15 2075-40 0817-20 1927-15 1156-01 1160-04 1156-02 1156-09 1160-06 1331-10 1331-11 1331-12 2072-34 1548-08 2262-18 2405-26 16M8-03 16R5-08 15B7-12 15D2-01 15D2-02 15D2-03 16P2-20 2720-20 2451-02 2451-06 2451-09 2468-18 1985-12 1860-15 2850-03 2850-04 2067-31 2086-28 0829-17 191305 2107-11 1848-01 1848-03 27Z0-15 2704-19 2047-39 0884-04 1421-11 2423-16 2423-17 1482-12 28E7-02 2413-02 2413-03 2486-05 2074-17 2486-04 2486-16 2327-23 2398-05 2438-15 2438-16 2479-09 2479-11 2311-07 2311-11 2425-11 2427-18 2227-07 2233-16 27X4-18 2427-21 2381-03 2382-04 2822-19 2867-07 2850-01 2382-06 2227-02 26C7-30 14H8-04 1017-06 1021-03 1021-05 2108-31 2108-32 2414-14 2367-11 2367-12 2451-19 2406-28 27M5-12 2368-20 2369-01 2398-14 26G4-01 26G4-09 1686-01 2369-05 16S0-01 2080-19 1874-06 26D8-26 26E4-14 26D5-24 26D4-26 26D4-27 2039-07 2585-27 26A4-26 2570-30 13A9-09 2240-13 2240-15 1914-18 2072-31 2072-18 2304-13 2362-19 1122-18 1924-13 2049-14 16R5-15 27L8-11 1868-08 2446-12 2535-20 28E7-16 2548-24 1387-17 1486-20 1490-17 14A3-04 14A3-05 14A3-06 14A3-07 1118-13 2534-05 2534-06 1872-12 2047-37 0884-02 2413-09 2891-15 26H1-28 2858-02 16J8-16 16J8-17 16K2-01 27P2-10 2704-20 2441-10 2441-11 2422-18 2425-12 2219-18 2234-07 1988-11 26B5-23 2379-13 2406-29 2407-04 2894-20 2896-01 1919-05 2102-31 1872-07 1476-03 1479-07 2576-21 185503 27S2-18 2228-15 1005-29 2413-11 2429-30 1263-20 27P2-16 27P2-17 2108-05 2108-21 2425-14 2039-13 2041-16 2413-06 26F1-17 27S4-04 27S4-05 2585-19 2585-21 2493-05 2493-19 1910-04 2422-29 26D6-02 26E0-16 2842-11 2107-31 2848-18 2193-39 27R3-06 27R3-08 27L1-09 2842-10 1914-20 0763-09 2347-15 2348-16 27Z8-08 1691-15 2427-25 2427-26 2207-08 2226-09 26C7-29 14H8-03 2577-02 2577-01 26D4-29 26D4-30 1927-09 2848-16 1459-12 1459-13 1476-05 1476-06 2073-10 26C3-07 190703 2049-21 2369-03 2587-10 2305-22 2070-21 27J7-09 2066-27 2103-40 26H3-26 2848-19 2061-36 0801-27 2581-23 2584-23 2584-30 2395-29 2396-02 1870-16 2073-38 2080-30 2578-24 13B8-11 2071-20 2071-21 2065-04 27W3-18 1344-01 1344-07 1344-08 2288-12 2288-07 27Z8-18 27Z8-19 28E7-13 28E7-14 2140-06 2140-07 2257-02 2079-30 16P1-10 1479-08 1476-07 1476-08 1476-09 1476-10 1988-02 2137-17 14A9-01 14A9-05 2563-30 27R8-19 15S9-19 26B4-26 27J7-02 26H6-26 27Y6-16 27S0-18 27S0-19 26D9-30 2473-07 2486-21 27M5-14 2368-03 1128-16 2319-06 28A3-02 2363-01 26H5-28 28D3-18 1122-20 14M7-18 1616-18 16X4-19 2711-01 2232-19 2708-15 26D6-04 26D8-24 1872-15 1873-05 2054-11 2193-11 2140-03 1855-33 1927-06 1927-20 2074-15 2107-07 2074-14 2209-20 2078-16 2085-33 2137-11 2347-16 1914-17 2358-18 1914-15 0763-06 1118-12 0763-04 15F5-15 15F5-16 2077-38 2078-20 15H2-05 16K4-05 2074-30 2408-22 2580-28 2580-29 1679-13 2497-02 2497-03 26A9-06 1138-10 1139-01 1127-08 1138-08 16M7-05 1988-06 2148-15 28E5-13 2486-27 2493-04 1912-20 0761-08 2374-11 1684-07 1684-08 1570-17 1479-06 1480-17 15F5-12 15F5-13 15H2-08 15H2-09 15D9-15 15D9-16 1691-19 1548-16 2126-08 15H7-15 15H7-16 15H7-17 15H7-18 2068-33 1857-12 2850-15 2106-17 2858-03 2858-04 27P2-07 27P2-08 26D8-20 1418-03 1418-04 1561-12 1925-04 16P4-11 16P4-12 16P4-16 16P4-17 16P4-18 2187-36 2187-37 2187-38 2331-01 2085-09 2086-17 2086-18 2086-15 2086-16 2086-19 2188-08 2188-09 2188-10 2188-36 2188-37 2188-38 2102-06 2102-07 2102-08 2253-16 2253-17 2253-18 2260-11 2260-12 2260-13 26H6-24 2493-27 1858-04 1681-09 1860-21 1861-24 2065-10 1860-20 1860-17 2050-04 2566-26 27P0-20 2850-16 16K6-11 16K6-12 16K6-13 16K6-14 16K6-15 16K6-16 2061-20 2085-12 2085-14 2283-15 2065-06 2081-07 2081-08 2081-09 2081-10 2081-11 2083-04 2083-05 2084-22 2084-23 2083-06 2083-07 2083-08 2188-31 2188-34 2188-35 2192-21 2192-22 2192-26 2192-27 2260-17 2260-18 2260-19 2260-20 2262-11 2262-12 2260-14 2260-15 2260-16 2071-25 2075-20 2263-15 2283-18 2451-17 2451-18 2347-19 2348-11 28E5-12 1733-15 2052-01 2052-02 16K6-17 16K6-18 16K6-19 2086-25 2086-26 2189-07 2082-39 2084-05 2084-12 2084-13 2084-14 2084-15 2084-06 2084-07 2192-31 2101-39 2257-08 2257-09 2257-10 2257-11 27S2-05 27S2-06 2050-06 2050-07 15D6-18 15D9-12 15D9-13 15D9-14 2071-22 2086-23 2086-24 2252-05 2255-20 2263-12 2084-08 2084-09 2084-10 2084-11 2085-04 2085-10 2188-04 2187-33 2188-39 2188-40 2102-03 2195-23 2146-17 2146-18 2146-19 2253-19 2253-20 2254-01 2257-04 2577-03 16K5-17 1616-17 27Z0-07 1905-05 1307-41 2050-01 1544-13 1536-04 2085-11 2084-19 2084-20 2084-21 2413-08 2891-14 2446-14 2446-16 1537-15 1989-20 2050-08 15H7-11 15H7-12 15H7-13 2082-40 2083-01 2084-16 2084-17 2084-18 2188-32 2189-37 2189-38 2189-39 2251-16 2251-17 2251-18 2452-01 2469-06 2232-18 2234-02 26C3-08 26C3-09 2488-02 2232-20 2039-10 1357-15 1357-16 1357-17 1357-18 26G8-08 27R8-20 15S9-20 2493-13 2493-15 2469-05 2469-07 2234-01 2348-17 2145-17 2850-12 2850-13 2145-11 2145-12 15D3-13 15D5-04 15D5-06 15D6-17 1308-35 1308-36 1419-12 1422-17 16J8-14 16J8-15 2079-18 2081-12 2192-18 2147-05 2147-06 2085-05 2085-07 2085-08 2190-14 2188-01 2119-14 28D7-19 1616-19 1921-01 1921-02 1537-17 1905-01 1905-02 2050-03 2050-05 15E3-04 15E3-05 15E3-06 15E3-01 15E3-02 15E3-03 2085-16 2085-17 2189-01 2189-05 2189-06 2256-01 2278-09 2081-06 2188-05 2188-06 2188-07 2190-17 2190-18 2190-21 2190-03 2190-04 2190-05 2189-40 2190-01 2190-02 2189-36 2192-24 2086-12 2106-28 2106-29 2110-09 2110-10 2188-02 2119-13 2056-21 2147-04 2251-15 2253-12 2253-13 2253-14 2257-05 2257-06 2257-07 2059-05 2140-08 2140-10 2473-02 2473-03 2076-22 1544-10 1733-18 1725-19 1857-27 1556-12 1681-08 1694-20 16M6-20 16M7-02 16M7-03 16M8-04 2076-19 2076-20 2076-21 2083-03 2085-18 2083-02 2085-13 2275-14 2275-15 2275-16 2278-07 2190-13 2190-15 2190-16 2192-28 2192-29 2290-05 2290-06 1711-16 2192-12 2189-04 2086-14 2086-20 2190-10 2190-19 2190-20 26E4-12 26H6-23 27L7-20 2069-01 2087-03 26D8-21 26D8-25 2873-01 2891-18 1921-03 1557-10 1736-07 1855-12 1905-03 1925-03 16J8-07 16J8-08 16J8-09 16J8-10 16J8-11 2080-03 2085-15 2252-04 2252-03 2278-08 2079-19 2080-01 2081-04 2190-06 2190-07 2190-08 2190-09 2190-11 2190-12 2192-25 2192-32 2252-02 2253-15 2251-19 2251-20 2283-16 2296-20 27S8-10 27S4-06 2486-14 2486-15 27R3-20 27R5-01 2869-18 16Z2-18 2107-04 2485-29 2487-28 2587-12 2145-08 2290-12 2486-02 2062-02 2467-03 2066-22 2066-23 2102-36 2708-19 2719-08 27R3-05 1556-16 1861-23 2581-21 2066-35 2066-36 26G4-18 26G4-11 26G7-22 26C9-13 26C9-14 2070-15 2472-10 2481-09 2195-36 1160-01 1160-05 1183-04 1217-09 1225-11 26E4-11 2212-19 2212-20 1864-17 1864-18 2427-13 2431-26 26D6-06 14A8-02 16L5-02 16L8-01 16L8-02 16L8-03 16P4-10 27M5-15 2399-09 2399-13 2399-04 2087-08 2585-18 1459-10 1459-11 2104-04 2104-07 2472-11 2472-12 2423-18 27X6-02 27X6-03 27X6-04 27J7-10 27S2-17 27S2-20 2493-26 2212-12 2212-13 2232-13 2232-14 2232-15 26E0-19 2145-13 26B5-24 26C3-05 26C3-06 2107-30 2137-12 2137-13 2581-16 2441-04 1684-05 1572-19 2192-10 2103-29 2104-06 2356-01 27P0-08 27S0-16 1571-13 1867-19 1935-18 1908-03 0756-30 1139-02 1139-03 1139-04 1139-05 2427-19 2427-20 2497-14 2305-23 2307-04 27S2-19 2543-04 27Z0-04 2059-23 2382-05 26G6-30 2358-14 2570-29 1118-08 13A9-08 2348-20 26E4-07 1684-06 2057-28 2487-30 1873-03 2535-22 2535-21 2049-16 27S0-20 186225 2395-28 2865-17 2533-21 1910-08 27S4-01 27P2-01 2485-30 26D8-23 26H6-25 2367-10 2439-14 2486-18 2389-15 1142-17 1860-22 2389-12 1142-14 2865-19 1310-20 1871-12 2069-24 2250-08 2256-14 27S2-01 2227-14 2547-30 2548-01 1925-07 2413-15 2565-21 2565-22 2577-05 2585-22 1556-17 1843-02 26F0-29 27L8-01 27L8-08 2409-26 26A4-27 26B6-30 14G5-06 2565-23 2565-28 2073-27 2079-39 2427-23 2427-24 2544-21 1383-03 2566-25 2566-30 2486-07 2402-28 2226-16 2226-18 26D6-11 26D8-28 2585-25 27M5-11 26A4-23 26A4-29 26A5-01 2587-13 26D0-25 26D0-26 26D5-30 26D9-25 26E0-14 26G4-13 2585-20 2432-29 2432-30 2432-24 1211-19 1211-04 1211-05 1335-08 1335-09 1335-10 1335-11 1910-06 2438-14 27L1-05 2077-40 2078-21 2535-12 2535-13 2535-14 2550-12 2550-14 2565-25 2565-26 27J6-19 2550-15 2564-23 2565-24 2108-30 14B1-03 14B1-04 2423-03 26B4-22 2072-40 2107-38 2229-12 2233-20 2450-17 2451-01 2446-17 2446-19 2406-25 27Z0-12 27P6-16 27P8-01 16R0-06 16R5-06 2581-14 2581-15 2706-01 2493-25 2867-09 2871-19 27R1-16 2355-01 2485-28 1931-09 2039-11 2224-17 2473-04 2473-06 2486-17 2714-09 2714-10 2458-23 1387-16 26F3-20 26G4-12 2581-17 2437-18 27J6-17 2486-13 27Z6-18 27Z6-19 2472-08 2472-09 27S2-15 2720-16 16X4-16 26G4-10 16K3-11 16K3-12 16K3-13 26H3-25 2427-16 2427-17 26H5-29 14M7-19 2396-18 2321-23 2321-24 2362-20 1122-19 1146-01 1146-02 1146-03 16K3-10 2071-40 2219-17 2229-14 2535-06 2535-07 27W3-19 27W3-20 2398-15 2398-16 2407-06 26D4-28 26D8-22 2256-17 26D0-21 26D1-30 2061-29 1139-06 1139-07 15H2-11 15H2-12 15H2-14 2585-06 28E7-12 28F7-02 1132-05 1132-10 1137-02 2423-21 2425-13 26H0-30 14M0-20 2350-04 2408-23 2409-23 2432-25 1924-12 1935-17 2073-37 2042-03 2497-11 2140-12 2704-16 27L1-15 2220-06 2444-07 26F0-18 2080-25 2106-10 28E9-12 28F5-13 16R5-07 14B1-07 15B7-07 15B7-13 2842-14 2842-15 1853-03 1860-16 1733-16 1736-03 2070-01 2070-02 1601-03 1705-20 1208-05 1211-07 1211-08 2330-20 2409-24 2409-25 2107-18 1139-08 1139-10 1140-07 1140-10 1140-08 1156-06 1158-09 1156-07 14B3-08 14B3-09 14B3-10 2369-02 2564-21 2564-22 2227-09 1572-20 1673-01 27Y6-11 27Z0-06 27Z0-11 2413-12 2413-13 1928-01 1848-04 1925-08 1909-09 1909-10 1926-03 2567-23 2423-05 1936-10 1171-10 1211-13 1988-12 1983-06 2494-22 2054-09 1563-04 26B4-21 16K7-12 16M7-06 2856-19 2869-17 2856-20 16Y8-19 16Z2-17 16Y8-20 16L3-20 16K7-11 1866-13 2427-30 2428-01 26A5-08 26A9-03 2304-30 2305-08 2137-06 2564-29 1984-01 2384-19 26A4-24 26A4-25 2048-06 2048-29 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26H3-27 2848-11 26D8-19 26D8-27 2479-08 1601-02 1858-05 2317-18 2332-11 2332-12 2396-13 2398-06 2312-27 2332-20 26D0-24 1853-02 1855-10 1855-11 1858-02 1858-03 1849-02 1853-01 1691-14 1860-12 1860-13 1860-14 1860-11 2104-21 2104-03 2368-04 1128-17 2070-22 2581-19 2581-20 27J6-20 27X4-16 27X4-17 2850-07 2850-08 1146-05 1146-06 1147-04 1485-11 2067-30 2070-40 2414-10 2414-11 2414-12 2427-22 2430-28 2431-24 2431-25 26D9-29 26E4-09 2850-11 28B6-19 1611-19 2192-16 27Z8-10 27Z8-11 26G4-19 2858-05 2860-20 2368-13 2369-13 2304-12 1131-08 1132-01 1132-02 15J6-10 2144-13 2140-04 2894-09 2894-16 2894-17 1983-09 27Z8-15 2822-11 28D7-20 28F5-18 2432-27 1862-27 2719-09 2304-29 2305-09 2566-28 2566-29 2073-09 2059-40 2422-23 2422-24 2149-13 2430-30 2431-21 2431-22 2108-25 2108-26 1988-14 2494-27 2209-09 2209-10 26B6-29 14G5-05 2072-28 27J7-05 26G7-21 2073-40 27Z8-17 2848-13 26F0-30 2534-04 2534-03 2535-09 2535-10 2535-11 2405-28 2405-29 26B3-28 2544-22 2550-18 2488-04 27W5-01 1338-12 1338-13 1338-14 2202-11 2292-17 143115 2209-19 2327-26 1988-10 2056-09 2056-12 1559-13 1539-13 1539-14 1571-12 1480-19 1490-09 1490-13 1490-14 1491-01 15B7-08 28F5-14 2468-17 28E7-15 2432-22 2432-23 190520 2149-12 2104-08 2104-20 1867-16 1156-04 2444-14 1868-02 2423-04 2535-05 2192-13 2196-03 2497-15 2422-16 2137-03 2137-04 1698-05 1711-17 1991-13 1991-14 2233-17 2233-18 2543-11 2543-12 1544-06 26F1-18 26H6-28 26G4-14 2071-23 27Y6-14 2422-28 2423-20 2056-10 2056-13 2581-24 2585-23 2086-36 2108-37 2047-38 0884-03 16L7-18 16P4-01 2085-30 2087-11 26F0-28 26F1-16 27X8-20 15V4-20 2321-22 16P1-12 16P3-02 16P3-03 1865-19 1999-20 1861-20 15H7-19 15H7-20 15H8-01 15H8-09 15H9-13 15H9-14 15H9-15 15H9-16 15J0-03 15J0-04 15J0-06 15J0-08 16K4-01 16K4-02 16K4-03 16K4-04 16K5-07 16K5-08 2267-20 2262-19 2262-20 2221-03 199902 2414-09 2535-08 2385-02 2385-03 2327-12 2867-02 2427-14 2427-15 2234-08 2234-09 2236-10 1008-10 16K6-20 16K7-01 16K7-02 16K7-03 2486-12 2389-16 1142-18 1461-05 1468-18 1468-19 1468-20 2330-16 2330-18 1171-07 1171-08 1171-09 1173-10 1160-08 1171-06 1174-06 1174-07 2275-11 2278-10 2278-11 2330-19 2140-02 2262-17 2267-17 2267-18 2283-17 2330-17 2585-01 2585-02 2585-03 2585-16 2585-17 2399-05 2399-07 2233-15 2891-19 2079-29 15G9-03 15G9-04 2494-29 26G3-30 27J7-12 2305-10 1142-09 1145-10 26E0-20 26E0-21 2293-05 1140-01 2052-05 26D5-23 2196-07 1858-35 26D0-22 26D0-23 2192-09 2322-08 2107-22 2107-23 2190-38 2195-10 2402-29 2195-01 2103-36 2321-29 2066-28 1139-09 1173-08 2070-07 2310-08 1334-15 1335-13 1459-14 14B2-14 2488-03 1428-07 1182-08 1211-06 1331-13 1338-15 1338-16 27S2-14 1147-05 1149-01 26C7-28 14H8-02 1926-04 2432-26 2432-28 2566-27 26E4-13 15J6-02 15J6-08 2427-28 2037-13 2059-12 2058-18 2429-28 1263-18 2148-14 2149-08 2149-20 16P6-19 16R7-03 2256-02 2076-18 2262-16 2414-13 2891-16 2891-17 2148-09 28E7-18 2086-31 0829-20 2894-18 2894-19 1601-01 1698-03 16P6-14 2058-23 1429-13 2250-01 2307-05 1919-02 1919-04 2220-02 2220-04 1469-02 2220-07 26A5-02 2850-14 2431-23 2471-20 27K0-06 1211-20 15B7-06 27R3-09 27R3-13 1907-02 2321-20 2438-04 2409-22 2408-20 15C8-11 14B1-05 14B1-08 2332-10 2438-13 26E0-15 2037-11 1991-17 1991-16 26H6-27 2061-40 0802-01 199010 27Z0-08 15R8-20 27J6-14 27J6-13 27J7-01 27J6-18 27Z8-07 27P2-09 2479-10 2493-17 26D5-21 2850-02 27X6-06 27Y6-09 187018 1925-13 27Z8-06 2488-01 26F1-21 2708-16 27Z8-14 2042-02 2321-27 26A9-10 27L1-12 27L1-13 27L1-03 27L1-04 27K9-16 27L1-01 27L1-02 1983-08 1868-14 2288-08 2328-02 2473-01 2077-36 1928-02 1924-11 2192-11 1149-07 1149-08 1156-03 1167-02 16R0-07 16R0-08 1863-05 27J7-11 27J9-12 27L1-06 1935-16 26G4-08 15C9-08 27L1-07 27L1-08 15C8-12 15C8-13 15C8-14 15C8-15 27L1-10 27L1-11 2301-05 2308-06 2229-03 2229-07 2067-33 27S2-16 27Z8-16 1698-06 1733-17 26D5-27 26E0-17 1862-16 27J6-16 1538-10 27Z2-09 2494-23 2494-24 2494-25 2494-26 28F5-15 28F5-16 16R5-04 16R5-05 2061-34 2064-05 2137-05 2227-12 2227-13 2413-10 2422-15 2226-19 2233-14 1016-05 1017-01 2102-04 2102-05 27R3-14 27R3-16 2578-23 13B8-10 2708-20 27Z6-20 2867-04 2486-22 16L8-08 16M4-14 16M4-15 16M4-16 16M7-04 2550-16 2563-29 1905-06 2848-10 2842-04 2061-37 2061-38 0801-28 0801-29 2413-07 2422-19

Source

Dataset
openFDA device recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for Z-0378-2018
openFDA file date
Oct 23, 2026
Loaded by RegDataLab
Oct 26, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.