Lower riskMedical device recall · FDA · Published August 27, 2020
Roche Albumin Gen.2: Yellow Discoloration from Cross Contamination
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 Albumin Gen.2: Yellow Discoloration from Cross Contamination.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64422-roche-albumin-gen-2-yellow-discoloration-from-cross-contamination. Based on FDA recall #Z-0104-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0104-2021%22&limit=1).
Roche Diagnostics Operations, Inc. recalled Albumin Gen.2 reagents on Aug. 27, 2020, after the FDA announced the Class III recall due to potential invalid calibrations and low quality control recovery. The agency cited cross-contamination causing yellow discoloration as the cause.
How to tell if you have it
Brand: Roche
Product: Albumin Gen.2
Catalog number: 05166861190
Lot codes: 43031001, 43718901
The hazard
Roche confirmed customer complaints of low quality control recovery and invalid calibrations. The hazard stems from cross-contamination between R1 and R3 reagents, which results in a yellow discoloration.
Context
GovInfoNow's records show Roche Diagnostics Operations, Inc. has 32 other recalls on record since July 2, 2019. Recent similar recalls include the Roche cobas pro integrated solutions recall (Jan. 20, 2026), the Roche Elecsys Anti-TSHR Assay Recall (Nov. 21, 2025), and the Roche cobas HCYS Assay Recall (Oct. 17, 2024). Other recent recalls of similar products include the Siemens Atellica CH Urine Albumin Recall (July 6, 2026).
How to tell if you have this one
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.
Brand
Roche
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class III
Status
Terminated
Distribution
Domestic distribution nationwide.
Recall number
Product, codes & lots
Quantity
Z-0103-2021
Tina-quant Complement C4 ver.2, Catalog 05991994190; lot 36870301
180 units
Z-0104-2021
Albumin Gen.2, Catalog 05166861190; lots 43031001, 43718901
11963
Based on the official FDA remedy
What to do — step by step
Check for Yellow Discoloration
Look for yellow discoloration in the test kit, which indicates cross contamination between reagents.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “Domestic distribution nationwide.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 3.7 years after the firm started it.
1Firm started the recall
2FDA classified it Class III
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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.
Official source: FDA Recall #Z-0104-2021 (August 27, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0104-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.