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

Recall Z-0379-2017 — ARCHITECT Lactic Acid Part # 09D891T21 The Lactic Acid assay is used for the quantitation of lactic acid in human plasma.

U.S. FDA — Device Enforcement · United States · 2016-10-11 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0379-2017
Date of alert
2016-10-11
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Abbott Laboratories
Product category
device
Product type
Devices
Reported risk: Abbott has identified negative interference from the drug N-Acetyl Cysteine (NAC) with the ARCHITECT Lactic Acid reagent (LN 9D89-21).
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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