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

Recall Z-1653-2016 — Advia Chemistry Assay: Direct HDL Cholesterol (D-HDL)

U.S. FDA — Device Enforcement · United States · 2016-03-17 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1653-2016
Date of alert
2016-03-17
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Siemens Healthcare Diagnostics, Inc.
Product category
device
Product type
Devices
Reported risk: Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone) interference with Trinder and Trinder-like reaction assays. Siemens has confirmed that falsely depressed results may occur on samples drawn from patients receiving N-Acetylcysteine (NAC) or Metamizole. NAC is the accepted antidote for acetaminophen toxicity and is justified in patients at signific
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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