Roche recalls CK tests for cobas c 311/501/502 and COBAS INTEGRA 400 plus analyzers due to potential calibration errors causing misdiagnosis. Affected lots expire June 2024.
Creatine Kinase (CK) Assay Abnormal calibrations on the cobas¿ c 311/501/502 and COBAS INTEGRA 400 plus Analyzers may lead to erroneous results and misdiagnosis.
Roche is recalling creatine kinase (CK) tests used with specific lab analyzers because faulty calibrations could lead to incorrect test results and misdiagnosis. This affects labs using the mentioned analyzers with the recalled test kits.
The CK test kits may have calibration issues that cause inaccurate results. If the analyzer gives wrong readings, it could lead to incorrect medical decisions and misdiagnosis of patient conditions.
Labs using Roche's cobas c 311/501/502 or COBAS INTEGRA 400 plus analyzers with the recalled CK test kits are affected. Lab technicians and medical staff who rely on these tests for patient diagnosis are most at risk.
Check for the catalog number 07190794190 or UDI-DI 04015630940806 on the test kit. The lot number 755471 with an expiration date of June 30, 2024, is also specific to this recall.
Look for the catalog number 07190794190 or UDI-DI 04015630940806 on the test kit.
The test kits may have calibration issues that could lead to inaccurate results and misdiagnosis.
The official recall notice does not specify a remedy for this issue.
The recalled test kits have an expiration date of June 30, 2024.
We’ve drafted a message you can send Roche to request your refund or repair — edit it as you like.
Subject: Recall Z-3187-2024 — Roche Roche Hello, I own a Roche that is covered by recall Z-3187-2024 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.
