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

Recall Z-1024-2015 — Beckman Coulter, Uric Acid Assay, Catalog No. OSR6X98

U.S. FDA — Device Enforcement · United States · 2014-12-15 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1024-2015
Date of alert
2014-12-15
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Beckman Coulter Inc.
Product category
device
Product type
Devices
Reported risk: N-Acetyl Cysteine (NAC), when administered in therapeutic concentrations for the treatment of acetaminophen overdose, interferes with the assays for these analytes: Cholesterol OSR6X16, Uric Acid OSR6X98, Lactate OSR6X93, and Lipase OSR6X30. NAC interference may lead to falsely low results.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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