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

Recall Z-1712-2017 — ADVIA Chemistry Enzyme 2 Calibrator, multi-analyte mixture Product Usage: Assays included in Enzyme 2 Calibrator: AST, AST_c ALT, ALT_c, ALTP5P, ALTP_c, ASTP5P and ASTP_c

U.S. FDA — Device Enforcement · United States · 2017-02-23 · Class III

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1712-2017
Date of alert
2017-02-23
Country / jurisdiction
United States
Risk level
Class III
Risk type
recall
Brand
Siemens Healthcare Diagnostics, Inc.
Product category
device
Product type
Devices
Reported risk: Siemens Healthcare Diagnostics has confirmed a positive bias of up to 41% in quality control and patient results for Aspartate Aminotransferase (AST) and Aspartate Aminotransferase concentrated (AST_c) assays following calibration with Advia Chemistry Enzyme 2 Calibrator lots 6JD079 and 6MD042.
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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