PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: November 16, 2016 Initiated: October 11, 2016 #Z-0379-2017

Product Description

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

Reason for Recall

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

Details

Recalling Firm
Abbott Laboratories
Units Affected
26, 837 kits
Distribution
Nationwide and Worldwide Distribution.
Location
Abbott Park, IL

Frequently Asked Questions

What product was recalled?
ARCHITECT Lactic Acid Part # 09D891T21 The Lactic Acid assay is used for the quantitation of lactic acid in human plasma.. Recalled by Abbott Laboratories. Units affected: 26, 837 kits.
Why was this product recalled?
Abbott has identified negative interference from the drug N-Acetyl Cysteine (NAC) with the ARCHITECT Lactic Acid reagent (LN 9D89-21).
Which agency issued this recall?
This recall was issued by the FDA Devices on November 16, 2016. Severity: Moderate. Recall number: Z-0379-2017.