Reported Mar 14, 2018 · Terminated
cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 +…
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
Is this the product you have?
4 of 4 products
| # | Product as published |
|---|---|
| 1 | 04745914001 cobas c 501 module |
| 2 | 05036453001 cobas 6000 UL c 501 + Core Fix configuration |
| 3 | 05036453692 - cobas 6000 UL + CORE CU; and |
| 4 | 05860636001 cobas 6000 c 501 (UL) V |
- Lot codes and dates
- Serial numbers
3,433 of 3,433 codes
0948-270933-271214-111297-080947-230932-231113-2216U0-0216Z4-021246-121255-0814F9-1514F9-1614M9-1514M9-160963-170949-120967-130953-281741-1014A3-1414D5-0114D5-1714K0-171163-131163-141146-131146-141166-181149-181146-151148-161113-251113-261157-011157-021113-131113-1416Z6-020809-220888-220762-150770-070756-150770-140756-220825-280806-281175-111161-110809-290888-2915K6-1015U2-100626-070748-130749-100629-120747-0114J2-18
- Serial numbers
- Amount recalled
- 3433
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
A warning is being added to the cobas¿ 6000 MODULAR Series System - c501 and the cobas¿ 8000 MODULAR Analyzer Series - c502 Operator Manuals to prevent operator injury during maintenance.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Roche Diagnostics Corporation recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.