Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0104-2021 — Albumin Gen.2, Catalog 05166861190

U.S. FDA — Device Enforcement · United States · 2020-08-27 · Class III

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0104-2021
Date of alert
2020-08-27
Country / jurisdiction
United States
Risk level
Class III
Risk type
recall
Brand
Roche Diagnostics Operations, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
43031001
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.