Roche recalls Albumin Gen.2 (Catalog 05166861190) due to yellow discoloration from cross contamination between reagents, causing invalid calibrations and low quality recovery.
Roche has confirmed customer complaints of low quality (QC) recovery and invalid calibrations for the identified products. A discoloration (yellow color) was observed and is the result of cross contamination between the R1 and R3 reagents.
Roche is recalling Albumin Gen.2 test kits because they can turn yellow due to cross contamination between reagents, leading to invalid calibrations and poor test results. This affects users who rely on these kits for accurate testing.
The test kits can develop a yellow discoloration due to cross contamination between the R1 and R3 reagents. This leads to invalid calibrations and low quality recovery of test results, meaning the tests may not be accurate.
Users of Albumin Gen.2 test kits with catalog number 05166861190, particularly those in clinical labs or medical settings that use these kits for blood tests. The risk is low as the issue does not cause immediate harm but affects test accuracy.
Check for Albumin Gen.2 test kits with catalog number 05166861190, specifically lots 43031001 and 43718901. The kits may show a yellow color indicating cross contamination.
Look for yellow discoloration in the test kit, which indicates cross contamination between reagents.
The yellow discoloration is caused by cross contamination between the R1 and R3 reagents, leading to invalid calibrations and low quality recovery.
Check if the kit has the catalog number 05166861190 and lots 43031001 or 43718901. If it shows yellow discoloration, it should not be used.
No, the issue does not cause immediate harm but can lead to inaccurate test results if the kit is used.
We’ve drafted a message you can send Roche to request your refund or repair — edit it as you like.
Subject: Recall Z-0104-2021 — Roche Roche Hello, I own a Roche that is covered by recall Z-0104-2021 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.
