Abbott Laboratories: Medical Device Recall in 2016 - (Recall #: Z-0379-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: October 11, 2016

Date Posted: November 16, 2016

Recall Number: Z-0379-2017

Event ID: 75448

Reason for Recall:

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

Status: Terminated

Product Quantity: 26, 837 kits

Code Information:

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

Distribution Pattern:

Nationwide and Worldwide Distribution.

Voluntary or Mandated:

Voluntary: Firm initiated