Roche recalls Iron Gen 2 reagent cassettes for inaccurate iron test results on certain analyzers. Affected units may show elevated results or control recovery issues. Consumers should contact Roche for details.
Roche received several complaints regarding increased control recovery and discrepant elevated results for the Iron Gen.2 (IRON2) assay on the cobas c311, 501, and 502 analyzers and on the COBAS Integra 400 plus analyzer.
Roche is recalling Iron Gen 2 reagent cassettes that may cause inaccurate iron test results on specific analyzers. This could lead to incorrect health assessments if used without correction.
The reagent cassettes may produce elevated results or inconsistent control recovery on certain analyzers. This could lead to incorrect iron measurements in patient tests, potentially affecting health decisions.
Healthcare facilities using Roche cobas c311, 501, 502, or Integra 400 plus analyzers with the affected reagent cassettes. Lab technicians and patients relying on these tests are at risk of inaccurate iron measurements.
Check for the catalog number 03183696122 on the reagent cassette. The product is used for iron testing on Roche/Hitachi cobas c and Integra systems. The unique device identifier (UDI) is 04015630918904.
Reach out to Roche for specific guidance on affected units and next steps.
Roche received complaints about increased control recovery and discrepant elevated results for the Iron Gen 2 assay on certain analyzers.
Cobas c311, 501, 502, and COBAS Integra 400 plus analyzers.
Look for catalog number 03183696122 on the reagent cassette or unique device identifier 04015630918904.
We’ve drafted a message you can send Roche to request your refund or repair — edit it as you like.
Subject: Recall Z-1675-2021 — Roche Roche Hello, I own a Roche that is covered by recall Z-1675-2021 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.
