FDAClass IINovember 16, 2016

ARCHITECT Lactic Acid recall

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

Why was ARCHITECT Lactic Acid recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot: 31497UN14 Exp.: 17 Oct. 2016; Lot: 09353UNI15 Exp.: 12 Feb. 2017; Lot: 45216UN15 12 May 2017; Lot: 14596UN15 Exp.: 30 Jul. 2017; Lot: 37055UN15 Exp.: 12 Oct. 2017; Lot: 14782UN16 Exp.: 21 Apr. 2018

Product
ARCHITECT Lactic Acid Part # 09D891T21 The Lactic Acid assay is used for the quantitation of lactic acid in human plasma.
Recalling firm
Abbott Laboratories
Quantity
26, 837 kits
Distribution
Nationwide and Worldwide Distribution.
Recall date
November 16, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls