Albumin Gen — Class III medical device recall Z-0104-2021
Terminated recall by Roche Diagnostics Operations, Inc., reported 2020-10-21, distributed nationwide. Roche has confirmed customer complaints of low quality (QC) recovery and invalid calibrations for the identifi
| Recall number | Z-0104-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Roche Diagnostics Operations, Inc., Indianapolis, IN, United States |
| Recall initiated | 2020-08-27 |
| Classified | 2020-10-13 |
| Reported by FDA | 2020-10-21 |
| Terminated | 2024-05-22 |
| Distributed | Nationwide (US) |
| Quantity | 11,963 |
| Lot numbers | 43031001, 43718901 |
| Model numbers | 05166861190 |
Product
Albumin Gen.2, Catalog 05166861190
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0104-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.