Recall Z-0379-2017— Abbott Laboratories

Name: FDA recall Z-0379-2017
Creator: U.S. Food and Drug Administration
Published: 2016-10-11

Class II · Terminated

Class II FDA medical device recall by Abbott Laboratories, initiated 2016-10-11, terminated 2017-05-17. FDA's recall record names no specific 510(k) clearance for this event. Product: ARCHITECT Lactic Acid Part # 09D891T21 The Lactic Acid assay is used for the quantitation of lactic acid in human plasma.. Reason: Abbott has identified negative interference from the drug N-Acetyl Cysteine (NAC) with the ARCHITECT Lactic Acid reagent (LN 9D89-21)..

Recalling firm: Abbott Laboratories
Classification: Class II
Status: Terminated
Initiated: 2016-10-11
Terminated: 2017-05-17
Firm location: Abbott Park, IL, United States

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).

Data sourced from openFDA. This site is unofficial and independent of the FDA.