Roche recalls specific lots of Elecsys CA 19-9 reagent for possible false high results affecting pancreatic cancer monitoring. Affected lots include 416245 and others listed. No action needed for most users.
The firm has received an increased number of complaints concerning non-reproducible elevated results ("high flyers") for one lot of Elecsys CA 19-9 reagent, which may affect clinical interpretation.
Roche is recalling certain lots of Elecsys CA 19-9 reagent used for pancreatic cancer testing because some samples may show falsely elevated results. This could lead to incorrect clinical decisions if not addressed.
The reagent may produce non-reproducible elevated results ("high flyers") in some tests, which could lead to incorrect clinical interpretations. This might affect treatment decisions for pancreatic cancer patients.
People using the Elecsys CA 19-9 reagent for pancreatic cancer testing, especially those with the affected lots listed. Laboratory staff and healthcare providers are most at risk.
Check the lot number on the reagent vial. Affected lots include 416245, 46449, 50474, 525510, and 568976. The product is sold under the brand name Roche.
Look for the lot number on the reagent vial to determine if it is affected.
No action is needed for most users. Only affected lots may require checking.
Affected lots include 416245, 46449, 50474, 525510, and 568976.
The recall note mentions a workaround for additional released lots, but no specific fix is stated.
We’ve drafted a message you can send Roche to request your refund or repair — edit it as you like.
Subject: Recall Z-1444-2020 — Roche Roche Hello, I own a Roche that is covered by recall Z-1444-2020 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.
