FDA Device recall Z-0104-2021
Albumin Gen.2, Catalog 05166861190
- FDA Device
- Class III
- terminated
- Published 2020-10-21
On 2020-10-21 the FDA classified a Class III recall of Albumin Gen.2, Catalog 05166861190 by Roche Diagnostics Operations, citing 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 r….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0104-2021 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2020-08-27 |
| Published | 2020-10-21 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Roche Diagnostics Operations |
| Distribution | US |
Product
Albumin Gen.2, Catalog 05166861190
Reason
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.
Identifiers
| code_info | lots 43031001, 43718901 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0104-2021%22
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