Roche recalls COBAS INTEGRA 400 plus analyzers used in specific lipid tests due to potential carry-over errors affecting results. Affected units include Tina-quant Apolipoprotein A-1 ver.2 and other assays with catalog numbers listed.
COBAS INTEGRA¿ 400 plus and cobas c 111 analyzers Additional Extra Wash Cycle Configurations and/or Batch Mode Needed for Specific Tests Due to Carry-over
Roche is recalling COBAS INTEGRA 400 plus analyzers used in certain lipid tests because of a risk of carry-over errors. This could lead to inaccurate test results for lipoproteins, albumin, and creatinine. Affected units have specific catalog numbers listed in the recall notice.
The analyzers may produce carry-over errors when running specific tests, leading to inaccurate lipid measurements. This happens because residual substances from previous tests can contaminate the sample, causing incorrect results for apolipoprotein A-1, albumin, creatinine, and triglycerides.
Healthcare facilities using Roche COBAS INTEGRA 400 plus analyzers for lipid tests are most at risk. Patients receiving inaccurate test results due to carry-over errors may need retesting.
Check if your analyzer is used with Tina-quant Apolipoprotein A-1 ver.2 (catalog 03032566122), Tina-quant Albumin Gen.2 (catalog 04469658190), Creatinine plus ver.2 (catalog 03263991190), or triglycerides (catalog 20767107322).
Identify if your COBAS INTEGRA 400 plus analyzer is used with the listed test kits and catalog numbers.
The recall affects Tina-quant Apolipoprotein A-1 ver.2, Tina-quant Albumin Gen.2, Creatinine plus ver.2, and triglycerides tests with specific catalog numbers.
The analyzers may produce carry-over errors when running specific tests, leading to inaccurate lipid measurements.
No, the recall does not require stopping use; healthcare facilities should check if their analyzer is affected and follow the provided steps.
We’ve drafted a message you can send Roche to request your refund or repair — edit it as you like.
Subject: Recall Z-1124-2019 — Roche Roche Hello, I own a Roche that is covered by recall Z-1124-2019 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.
