Reported Sep 4, 2019 · Terminated
Roche Elecsys Anti-CCP Immunoassay Catalog # 05031656160
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?
- Roche Elecsys Anti-CCP Immunoassay Catalog # 05031656160
- Lot codes and dates
- Lot # 376808 Exp 08/31/2019 Lot # 389165
- Exp 09/30/2019 Anti-CCP assayAnti-CCP Elecsys cobas e 100 The affected lots of Anti-CCP have been distributed 02/28/2019 through 07/01/2019. ***Updated 7/17/20*** Current (in-date) and future lots of both Catalog numbers are impacted
- In-date lots
443981exp. 07/31/2020 457164exp. 09/30/2020
- Amount recalled
- 550
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
Performance issues with certain lots of the Elecsys Anti-CCP assay on the cobas e 411 analyzer; MODULAR ANALYTICS E 170 module; and cobas e 601, 602, and 801 modules with plasma samples.
This product could cause temporary or reversible health problems — stop using it.
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