Roche recalls Anti-HAV IgM test system with material no. 11820591160 due to potential for erroneous results when used on cobas e 602 analyzers. Affected units may show incorrect hepatitis A infection results.
Potential for erroneous result messages for the Anti-HAV IgM assay when run on the cobas e 602 module. Discrepant result reporting may result.
Roche is recalling its Anti-HAV IgM test system (material no. 11820591160) because it can produce incorrect results when run on cobas e 602 analyzers. This could lead to wrong diagnoses of hepatitis A infections, which is serious for people needing accurate testing.
The test system can produce erroneous result messages when used with the cobas e 602 module. This means it might show false positive or negative results for hepatitis A infections, leading to incorrect diagnoses.
Laboratory users who run the Roche Anti-HAV IgM test system on cobas e 602 analyzers may be affected. Those at highest risk are patients needing hepatitis A testing where accurate results are critical.
Check for the material number 11820591160 on the test system. The product is used with cobas e 602 analyzers for hepatitis A testing in laboratories.
Look for the material number 11820591160 on the test system packaging or label.
The Roche Anti-HAV IgM test system can produce erroneous results when run on cobas e 602 analyzers, which may lead to incorrect hepatitis A infection diagnoses.
Check the product label for material number 11820591160. If you have this model, contact Roche for guidance on next steps.
This recall is for potential inaccurate results, not immediate safety risks. It does not pose a risk of injury or death but could lead to incorrect hepatitis A diagnoses.
We’ve drafted a message you can send Roche to request your refund or repair — edit it as you like.
Subject: Recall Z-0784-2019 — Roche Roche Hello, I own a Roche that is covered by recall Z-0784-2019 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.
