Device product

Albumin Gen.2, Catalog 05166861190

Z-0104-2021

August 27, 2020

Class III

Product summary

Firm: Roche Diagnostics Operations, Inc.
Event: Event 86406
Status: Terminated
Classification: Class III
Quantity: 11963
Official record key: device-enforcement:Z-0104-2021

Official wording

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.

Code information: lots 43031001, 43718901

Distribution pattern: Domestic distribution nationwide.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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.