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Recall Observatory FDA recall evidence

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.