Z-0910-2018 Class II Terminated
FDA device recall Z-0910-2018 was initiated by Roche Diagnostics Corporation on July 18, 2017 and is designated Class II. Reason for recall: A warning is being added to the cobas¿ 6000 analyzer and the cobas¿ 8000 modular analyzer series Operators Manual to prevent operator injury during maintenance. The recall status is terminated (terminated July 13, 2018). Affected quantity: 245.
Recall Details
- Product Type
- Devices
- Report Date
- March 14, 2018
- Initiation Date
- July 18, 2017
- Termination Date
- July 13, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 245
Product Description
cobas 8000 Modular Analyzer Series; Part Numbers: 1. 05964067001 cobas 8000 c 502 module
Reason for Recall
A warning is being added to the cobas¿ 6000 analyzer and the cobas¿ 8000 modular analyzer series Operators Manual to prevent operator injury during maintenance.
Distribution Pattern
Distributed in all 50 states: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MN, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, the District of Columbia, and Puerto Rico.
Code Information
Serial Numbers: 16C4-09 1475-01 1476-05 15A1-03 15A1-05 16B3-10 1474-06 1138-10 1140-10 1485-06 1590-01 1475-05 1484-05 1484-06 1012-06 1482-02 1481-10 1254-07 1487-07 1482-09 1482-10 16B7-08 16B8-06 1010-03 1020-09 15A2-02 1247-02 1267-06 15A2-03 1267-01 1369-02 16B5-08 16B3-03 15A5-04 15A5-03 1124-03 1125-04 1591-04 1591-05 1474-09 1474-08 1009-05 1021-08 1139-03 1140-09 1267-02 1267-03 1140-06 16B1-02 16B1-03 1138-04 1138-09 16B4-03 16C3-03 1485-07 1597-09 1011-10 1018-10 16C7-08 16C4-07 1475-02 1475-04 1476-07 16C4-10 16C5-10 15A4-04 15A4-05 1267-07 1474-07 1266-08 1267-09 1256-02 1256-03 1125-05 1369-08 15A6-04 15A7-03 1020-05 1124-04 1123-08 1485-09 1597-04 15A0-03 16C1-05 16C1-06 16C1-07 1267-08 1594-02 1594-04 1594-05 1594-06 1595-01 1595-06 1597-02 1597-03 15A3-01 15A4-01 16B0-02 16B0-03 16B0-04 16B8-03 16B8-04 16B5-09 16B8-01 16B2-07 16B2-08 1266-06 1266-07 1591-01 1591-02 16B1-07 16B2-05 16B2-06 16B1-01 16B4-10 16B5-01 15A6-02 15A6-03 15A6-06 1253-06 16B5-04 16B5-05 1592-01 1592-06 1592-07 16C7-09 16D0-10 1138-07 1139-05 16B1-04 16B1-05 1369-04 1124-05 1124-06 1139-01 1139-02 1253-04 1253-03 1251-03 1251-07 1482-03 1483-07 16C2-03 16B0-05 16B0-06 16B0-01 1124-09 1124-10 15A5-02 16A9-06 1017-04 1122-04 16C5-03 1483-09 1483-10 15A4-06 1012-08 1131-02 1131-03 1137-08 1139-04 1592-10 1597-06 1597-07 1597-08 16B4-01 16B4-02 16B6-05 16C3-04 16C4-06 16B7-05 16B7-06 1476-04 1475-03 16B8-05 16B8-09 1139-06 1591-07 16C1-04 1135-02 1137-07 1266-09 1266-03 1267-04 1472-05 1592-09 1592-08 1138-05 1266-05 1254-09 1254-10 1485-05 1019-03 1132-03 1472-02 1474-10 1132-04 1132-05 1021-04 1021-06 1247-01 1253-07 1472-03 1472-04 1477-06 1482-06 16C8-02 16C8-03 16B1-06 16B7-07 16B5-07 16B8-07 15A1-06 15A1-08 15A5-01 16B2-09 16B3-02 15A6-05 16A9-05 1123-05 1125-03 1251-06 1266-10 1140-07 1140-08 1254-08 1125-02 1132-09 16C1-10 16C1-09 1267-05 1253-05 1483-06 1483-08 1132-07 1133-09 16C1-02 1484-10 1484-09 1484-08 16C5-01 1015-07 1018-09 1123-06 16B6-04