Reported Feb 28, 2018 · Terminated

Cobas 8000 Modular Series system; Software Version 05-02 and 06-03; UDI: 05641446001

Roche Diagnostics Corporation

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Roche Diagnostics Corporation · 9115 Hague Rd · Indianapolis, IN · 46256-1025

Lot codes and dates: Serial numbers
399 of 399 codes
1030-08
1492-06
1492-08
15R9-05
15R9-06
15M9-04
15P2-08
16W0-09
16U1-05
16U1-09
16U1-10
16W4-07
1492-07
1167-07
1167-08
1206-05
1216-18
15F3-07
15H4-06
14A2-06
15F3-04
15F3-05
1015-05
14D2-03
14C9-06
14C9-09
1022-09
1020-01
1022-01
1022-05
1030-10
1029-09
1027-02
1362-01
1350-08
1350-07
1364-04
1364-05
1485-07
1485-08
1498-01
14A2-08
14C6-01
14D1-07
1207-09
15G6-09
15G6-10
15H4-07
1027-04
14C2-04
14C4-05
16Y5-09
16Y5-10
16Y9-07
1031-04
1138-04
15R9-01
15R9-02
1353-03
1344-09
Amount recalled: 399

A software failure may incorrectly set the system settings to "default" settings, creating a risk of incorrect results.

This product could cause temporary or reversible health problems — stop using it.

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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24 in total.