Roche recalls Tina-quant IgM Gen.2 test kits with specific catalog numbers due to potential interference issues that could affect lab test accuracy. Affected users should contact Roche for guidance.
New endogenous interference claims have been established for the following assays used on the cobas c 311 analyzer and the cobas c 501, 502, 701, 702, and Modular Analytics P/D modules which may have potential medical risk. ***Update: Cobas c111 and COBAS INTEGRA 400 plus analyzers are also impacted for BILT3 and LACT2 assays***
Roche is recalling specific Tina-quant IgM Gen.2 test kits because they may cause inaccurate lab results when used with certain analyzers. This could lead to incorrect medical diagnoses if the tests are not properly interpreted.
The test kits may produce false results when used with certain analyzers, potentially leading to incorrect medical diagnoses. This happens because of new interference issues identified in the test kits.
Lab technicians and healthcare providers using the recalled test kits with specific analyzers. Patients are not directly affected but may receive incorrect test results if their labs use the recalled kits.
Check for catalog numbers 03507190190, 05220726190, 03507041190, or 03507149190 on the test kits. The kits are used for IgM testing in human serum and plasma on clinical chemistry analyzers.
Look for the catalog numbers 03507190190, 05220726190, 03507041190, or 03507149190 on the test kit packaging.
Roche identified new endogenous interference issues that could lead to inaccurate lab results when the test kits are used with certain analyzers.
No, the recall does not require stopping use. Lab technicians should check the catalog number and contact Roche if they have the affected kits.
The affected analyzers include cobas c 311, cobas c 501, 502, 701, 702, Modular Analytics P/D modules, cobas c111, and COBAS INTEGRA 400 plus for specific assays.
We’ve drafted a message you can send Roche to request your refund or repair — edit it as you like.
Subject: Recall Z-1147-2019 — Roche Roche Hello, I own a Roche that is covered by recall Z-1147-2019 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.
