Z-0910-2018 Class II Terminated

Recalled by Roche Diagnostics Corporation — Indianapolis, IN

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