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

Recall Z-0152-2020 — Roche Diagnostics cobas Integra Albumin Gen.2 Catalog Number: 05166861190 - Product Usage: In vitro test for the quantitative determination of the albumin in human serum and plasma on Roche/Hitachi cobas c systems.

U.S. FDA — Device Enforcement · United States · 2019-09-11 · Class III

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0152-2020
Date of alert
2019-09-11
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)
33962301
Reported risk: Due to low Quality Control recovery and invalid Calibration.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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