Reported Jan 6, 2021 · Ongoing
Roche cobas 8000 modular analyzer series (i.e., cobas 8000 ISE module; cobas c 502, 701, and 702 modules; and cobas e…
Roche Diagnostics Operations, Inc.
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 Operations, Inc. · 9115 Hague Rd · Indianapolis, IN · 46256-1025
Is this the product you have?
3 of 3 products
| Model / number | Product as published |
|---|---|
| — | Roche cobas 8000 modular analyzer series (i.e., cobas 8000 ISE module |
| — | cobas c 502, 701, and 702 modules |
08763662001 | and cobas e 602 and 801 modules). Chemistry Analyzer (photometric discrete), for clinical use |
- Lot codes and dates
- Serial No.
1,050 of 1,050 codes
1017-011017-041019-091019-091019-091020-011022-051022-051029-091029-091030-081030-091030-091030-101034-091036-071036-071138-031138-031138-041140-091140-101142-011142-021142-021142-041142-041142-051142-061142-081142-081142-081142-091142-091142-091142-101143-011143-061143-091143-091143-101144-011146-021147-011147-031147-041147-071147-091149-011150-041150-051150-061150-061150-061150-061150-061161-051161-061161-081161-08
- Serial No.
- Amount recalled
- 1050 units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
Potential for Changed Configuration Settings on the cobas 8000 modular analyzer series/cobas pro integrated solutions, may cause incorrect results in several affected parameters. In the case of poor sample quality, discrepant results may remain undetected due to the absence of associated data flags.
This product could cause temporary or reversible health problems — stop using it.
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