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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