Albumin Gen.2, Catalog 05166861190
Reported: October 21, 2020 Initiated: August 27, 2020 #Z-0104-2021
Product Description
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.
Details
- Recalling Firm
- Roche Diagnostics Operations, Inc.
- Units Affected
- 11963
- Distribution
- Domestic distribution nationwide.
- Location
- Indianapolis, IN
Frequently Asked Questions
What product was recalled? ▼
Albumin Gen.2, Catalog 05166861190. Recalled by Roche Diagnostics Operations, Inc.. Units affected: 11963.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 21, 2020. Severity: Low. Recall number: Z-0104-2021.
Related Recalls
FDA Devices Moderate
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.2…
Vortex Surgical Inc. · 2026-02-11
FDA Devices Moderate
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conju…
Beckman Coulter, Inc. · 2026-02-11
FDA Devices Moderate
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These inst…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These in…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Produc…
Fujirebio Diagnostics, Inc. · 2026-02-11