Roche recalls Lactate Gen.2 test kits (catalog numbers 03183700190, 05171881190, 11822837190) that may cause inaccurate blood lactate results on certain analyzers, posing medical risks.
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 Lactate Gen.2 test kits that may produce inaccurate blood lactate results when used with specific lab analyzers, potentially leading to medical errors. This recall affects labs using the cobas c 311, c 501, c 502, c 701, c 702, and Modular Analytics P/D modules, as well as newer cobas c111 and INTEGRA 400 plus analyzers.
The test kits may cause false results due to new endogenous interference with certain lab analyzers. This interference could lead to incorrect blood lactate measurements, potentially affecting medical decisions.
Labs using Roche Lactate Gen.2 test kits with specific analyzers are affected. Medical professionals who run these tests are most at risk of inaccurate results.
Check for catalog numbers 03183700190, 05171881190, or 11822837190 on the test kit packaging. The kits are used with Roche cobas analyzers like the c 311, c 501, c 502, c 701, c 702, and Modular Analytics P/D modules.
Look for catalog numbers 03183700190, 05171881190, or 11822837190 on the test kit packaging.
The test kits may cause inaccurate blood lactate results due to new endogenous interference with certain lab analyzers, potentially leading to medical errors.
The recall affects cobas c 311, c 501, c 502, c 701, c 702, Modular Analytics P/D modules, cobas c111, and INTEGRA 400 plus analyzers.
The official recall notice does not specify a remedy, so no action is required beyond checking the catalog number.
We’ve drafted a message you can send Roche to request your refund or repair — edit it as you like.
Subject: Recall Z-1146-2019 — Roche Roche Hello, I own a Roche that is covered by recall Z-1146-2019 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.
