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Roche Diagnostics Operations, Inc. recalls Albumin Gen.2, Catalog 05166861190
Recalled October 21, 2020 · FDA recall Z-0104-2021 · Roche Diagnostics Operations
Hazard
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. · FDA Class III
Units
11963
Sold at
Domestic distribution nationwide.
Description
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.
Product
Albumin Gen.2, Catalog 05166861190
Manufacturer(s)
Roche Diagnostics Operations, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →