FDAFDA · Food and drugs·Recall number Z-0104-2021
Albumin Gen.2, Catalog 05166861190
Published October 21, 2020 · Recall initiated: August 27, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated
Recall details
- Manufacturer
- Roche Diagnostics Operations, Inc.
- Distributor
- Domestic distribution nationwide.
- Lot
- lots 43031001, 43718901
- Risk classification
- Class III
- Area (FDA)
- device
- Country
- United States
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