Medical device recalls Moderate risk

Abbott Laboratories recalls ARCHITECT Lactic Acid Part # 09D891T21 The Lactic Acid assay is used for the quantitation of lactic acid in human plasm…

Recall date
October 11, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0379-2017
FDA classification
Class II
Brand / firm
Abbott Laboratories
Sold / distributed
Nationwide and Worldwide Distribution.

Why it was recalled

Abbott has identified negative interference from the drug N-Acetyl Cysteine (NAC) with the ARCHITECT Lactic Acid reagent (LN 9D89-21).

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

ARCHITECT Lactic Acid Part # 09D891T21 The Lactic Acid assay is used for the quantitation of lactic acid in human plasma.

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