medical Class III Updated 2020-10-21

Roche Diagnostics Operations, Inc. recalls Albumin Gen.2, Catalog 05166861190

Recalled Product

Albumin Gen.2, Catalog 05166861190


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: lots 43031001, 43718901
View official government recall

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