Skip to content
Recall Observatory FDA recall evidence

Device product

cobas 8000 Modular Analyzer Series; Part Numbers: 1. 05964067001 cobas 8000 c 502 module

Z-0910-2018

July 18, 2017

Class II

Product summary

Firm
Roche Diagnostics Corporation
Event
Event 79130
Status
Terminated
Classification
Class II
Quantity
245
Official record key
device-enforcement:Z-0910-2018

Official wording

Reason: 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.

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

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.

Field note

Send feedback

We'll only use this to respond to your feedback.