Roche recalls specific lots of Elecsys Anti-CCP assay kits for performance issues with cobas e 411, e 170, and other analyzers. Affected lots distributed from Feb 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, leading to inaccurate test results. This could affect the reliability of the test outcomes for conditions like rheumatoid arthritis.
Users of Roche Elecsys Anti-CCP assay kits with cobas e 411, e 170, e 601, e 602, or e 801 analyzers who purchased the affected lots between February 2019 and July 2019 are likely impacted. Laboratory staff and healthcare providers using these kits are at the highest risk.
Check the lot number on the assay kit: 376808 (exp. 08/31/2019), 389165 (exp. 09/30/2019), 443981 (exp. 07/31/2020), or 457164 (exp. 09/30/2020). The kits were distributed from February 28, 2019, through July 1, 2019.
Look for lot numbers 376808, 389165, 443981, or 457164 on the assay kit.
Roche is recalling specific lots of Elecsys Anti-CCP assay kits that may cause performance issues with cobas e 411, e 170, e 601, e 602, and e 801 analyzers.
Affected lots include 376808 (exp. 08/31/2019), 389165 (exp. 09/30/2019), 443981 (exp. 07/31/2020), and 457164 (exp. 09/30/2020).
The affected lots were distributed from February 28, 2019, through July 1, 2019.
We’ve drafted a message you can send Roche to request your refund or repair — edit it as you like.
Subject: Recall Z-2362-2019 — Roche Roche Hello, I own a Roche that is covered by recall Z-2362-2019 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.
