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Type of Product Medical Device
TGA Recall Reference RC-2016-RN-01359-1
Product Name/Description ARCHITECT Lactic Acid. An in vitro diagnostic medical device (IVD)

List Number: 9D89-21

Lot Number: 31497UN14
Expiry: 17-Oct-2016

Lot Number: 09353UN15
Expiry: 12 Feb 2017

Lot Number: 45216UN15
Expiry: 12 May 2017

Lot Number: 14596UN15
Expiry: 30 Jul 2017

Lot Number: 37055UN15
Expiry: 12 Oct 2017

Lot Number: 14782UN16
Expiry: 21 Apr 2018

ARTG Number: 185778

Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 24/10/2016
Responsible Entity Abbott Australasia Pty Ltd Diagnostic Division
Reason/Issue Negative interference has been detected from the drug N-Acetyl Cysteine (NAC) used with the ARCHITECT Lactic Acid reagent (LN 9D89-21). The customer letter identifies the levels of interference observed at NAC concentrations of 80 mg/L (0.49 mmol/L) and 800 mg/L (4.9 mmol/L). Patients undergoing treatment with NAC may have falsely depressed Lactic Acid results. A falsely depressed result may lead a physician to mistakenly rule out lactic acidosis.
Recall Action Recall for Product Correction
Recall Action Instructions Take into account the newly provided interference levels when using the device. This action has been closed out on 14 June 2017.
Contact Information 1800 816 696 - Abbott Diagnostics