Roche recalls specific albumin test kits due to potential quality control issues affecting accuracy. Affected lots include 33962301 and 37437: 12/20/19 expansion.
Due to low Quality Control recovery and invalid Calibration.
Roche is recalling certain albumin test kits that may have quality control issues, which could lead to inaccurate results. This affects users who rely on these tests for medical diagnosis.
The test kits may have low quality control recovery and invalid calibration, which could lead to inaccurate albumin measurements in blood samples. This might result in incorrect medical diagnoses if used without proper calibration.
Users of Roche cobas Integra Albumin Gen.2 test kits with catalog number 05166861190 are affected. Laboratory staff and healthcare providers who use these kits for blood tests are most at risk.
Check for catalog number 05166861190 on the test kit. The affected lots are 33962301 and 37437301, expanded to include these lots on December 20, 2019.
Verify the catalog number and lot number on the test kit to confirm if it is affected.
The recall is due to low quality control recovery and invalid calibration, which could lead to inaccurate albumin measurements.
Lots 33962301 and 37437301 are affected, with the recall expanded on December 20, 2019.
No specific stop-use instruction is provided; check the kit details to confirm if it is affected.
We’ve drafted a message you can send Roche to request your refund or repair — edit it as you like.
Subject: Recall Z-0152-2020 — Roche Roche Hello, I own a Roche that is covered by recall Z-0152-2020 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.
