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

Recall Z-0722-2021 — Atellica Gamma-Glutamyl Transferase (GGT) Reagent - Product Usage: For in vitro diagnostic use in the quantitative determination of gamma-glutamyl transferase in human serum and plasma. Siemens Material Number (SMN): 11097597

U.S. FDA — Device Enforcement · United States · 2020-11-23 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0722-2021
Date of alert
2020-11-23
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Siemens Healthcare Diagnostics, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00630414596440
Reported risk: Gamma-Glutamyl Transferase (GGT) Reagent Low End Repeatability-Imprecision. Reagent may demonstrate a coefficient of variation (%CV) outside of the performance data for repeatability (within-run) listed in the Instructions For Use (IFU) on some analyzers.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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