Roche recalls specific lots of Elecsys Anti-CCP assay kits for performance issues with cobas e 411, E 170, and other analyzers. Affected lots were distributed from February 2019 to July 2019.
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.
Roche is recalling certain lots of Elecsys Anti-CCP assay kits that may cause performance issues when used with specific cobas analyzers. This could lead to inaccurate test results if the assay is not functioning properly.
The assay may not function correctly with certain cobas analyzers, potentially leading to inaccurate test results. This could affect the reliability of rheumatoid arthritis testing.
Patients using Roche Elecsys Anti-CCP assay kits with cobas e 411, E 170, or other analyzers for rheumatoid arthritis testing. Those who have the affected lots (distributed Feb 2019-July 2019) are most at risk.
Check the lot number on the assay kit: 376648 (exp 08/31/2019), 388800 (exp 09/30/2019), or current lots like 461913 (exp 07/31/2020) and 467132 (exp 09/30/2020). The kits were distributed from February 2019 through July 2019.
Look for lot numbers 376648, 388800, 461913, or 467132 on the assay kit.
The assay may not function correctly with certain cobas analyzers, potentially leading to inaccurate test results for rheumatoid arthritis testing.
Cobas e 411, E 170, and E 601, 602, 801 modules with plasma samples.
The recall record does not specify a remedy, so check with Roche for guidance.
We’ve drafted a message you can send Roche to request your refund or repair — edit it as you like.
Subject: Recall Z-2361-2019 — Roche Roche Hello, I own a Roche that is covered by recall Z-2361-2019 from Roche. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
