Roche recalls specific acetaminophen test kits due to rare risk of unreliable results from certain blood conditions. Affected lots from 2016-2018 may need replacement.
The previous version of method sheets for the Acetaminophen assay on the COBAS INTEGRA 400 plus/800/800 CTS analyzers and the MODULAR ANALYTICS P module are missing the following statement in the Limitations-interference section: "In very rare cases, gammopathy, in particular type IgM (Waldenstr¿m s macroglobulinemia), may cause unreliable results."
Roche is recalling specific acetaminophen test kits that could give unreliable results for people with rare blood conditions like Waldenstr¿m macroglobulinemia. This means test results might be inaccurate for those with very specific health conditions, though the risk is extremely rare.
The test kits may not work correctly for people with very rare blood conditions, particularly Waldenstr¿m macroglobulinemia. This can cause false results that might lead to incorrect medical decisions. However, this only happens in extremely rare cases and does not affect most users.
People who use Roche acetaminophen test kits with the specific lot numbers listed in the recall (2016-2018) are affected. Those with Waldenstr¿m macroglobulinemia or similar blood conditions are at slightly higher risk of inaccurate results.
Check the lot code on the test kit packaging. Affected lots include 11021500 (7/31/2016), 12361201 (5/31/2017), and other specific numbers from 2016 to 2018.
Look for the lot code on the test kit packaging to determine if it's affected. Affected lots are listed in the recall notice.
The recall is because the test kits may give unreliable results for people with very rare blood conditions like Waldenstr¿m macroglobulinemia, though this only happens in extremely rare cases.
No, the recall does not require stopping use. The risk is extremely low and only affects specific blood conditions.
Check the lot code on the test kit packaging. Affected lots include specific numbers from 2016 to 2018 as listed in the recall notice.
We’ve drafted a message you can send Roche to request your refund or repair — edit it as you like.
Subject: Recall Z-1519-2018 — Roche Roche Hello, I own a Roche that is covered by recall Z-1519-2018 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.
