Roche recalls Bilirubin Total Gen.3 test kits (model numbers 05795397190, 05795419190, 05795320160, 05795338160, 05795346160) due to potential incorrect bilirubin results on certain analyzers, which could affect medical decisions.
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 Bilirubin Total Gen.3 test kits that may give incorrect bilirubin results when used with certain lab analyzers. This could lead to inaccurate medical decisions if the test results are relied upon.
The test kits may produce incorrect bilirubin results when used with certain analyzers, which could lead to inaccurate medical decisions. This is due to new endogenous interference claims identified for these specific assays.
Healthcare facilities using Roche Bilirubin Total Gen.3 test kits with cobas c 311, c 501, c 502, c 701, c 702, Modular Analytics P/D modules, or updated cobas c111 and COBAS INTEGRA 400 plus analyzers are most at risk. Patients receiving bilirubin tests using these kits could be affected if results are inaccurate.
Check for model numbers 05795397190, 05795419190, 05795320160, 05795338160, or 05795346160 on the Bilirubin Total Gen.3 test kits. These kits are used with Roche/Hitachi cobas c systems for bilirubin testing in adults and neonates.
Look for model numbers 05795397190, 05795419190, 05795320160, 05795338160, or 05795346160 on the Bilirubin Total Gen.3 test kits.
No, the recall does not require immediate discontinuation. The test kits may need to be replaced if used with affected analyzers, but there is no urgent action needed.
The recall affects Roche/Hitachi cobas c 311, c 501, c 502, c 701, c 702, Modular Analytics P/D modules, cobas c111, and COBAS INTEGRA 400 plus analyzers.
Contact Roche Diagnostics Corporation for guidance on replacing the test kits with the correct version if they are used with affected analyzers.
We’ve drafted a message you can send Roche to request your refund or repair — edit it as you like.
Subject: Recall Z-1145-2019 — Roche Roche Hello, I own a Roche that is covered by recall Z-1145-2019 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.
