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[Recalled] ARCHITECT Lactic Acid Part # 09D891T21 The Lactic Acid assay is used for the quantitation of lactic acid in human plasma. — Abbott has identified negative interference from the drug N-Acetyl Cysteine (NA… | FDA 2016-10-11

recall fda device united-states

Regulators flagged this product in an official safety action. Here is what the notice says and what it means for owners.

Recall details

ProductARCHITECT Lactic Acid Part # 09D891T21 The Lactic Acid assay is used for the quantitation of lactic acid in human plasma.
Brand / manufacturerAbbott Laboratories
Categorydevice
Issuing authorityFDA_DEVICE
ReferenceZ-0379-2017
Country of noticeUnited States
Risk levelClass II
Hazard typerecall
Notice date11 October 2016

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: Abbott has identified negative interference from the drug N-Acetyl Cysteine (NAC) with the ARCHITECT Lactic Acid reagent (LN 9D89-21).

This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Check whether your unit is affected and follow the authority's guidance before further use.

Read the full official notice →

Related recalls from Abbott Laboratories

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.

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