Medical device manufacturer, Abbott Laboratories Limited, has issued a medical device safety alert concerning its ARCHITECT Lactic Acid [List number: 9D89-21; Lot number (Expiration date): 31497UN14 (17 Oct 2016); 09353UN15 (12 Feb 2017); 45216UN15 (12 May 2017); 14596UN15 (30 Jul 2017); 37055UN15 (12 Oct 2017); 14782UN16 (21 Apr 2018)].
The manufacturer has identified negative interference from the drug N-Acetyl Cysteine (NAC) with the ARCHITECT Lactic Acid reagent (LN 9D89-21).
According to the manufacturer, the levels of interference observed at NAC concentrations of 80 mg/L (0.49 mmol/L) and 800 mg/L (4.9 mmol/L) have been outlined in the Field Safety Notice (FSN). Patients undergoing treatment with NAC may have falsely depressed Lactic Acid results.
The affected users are advised to take the following actions:
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 13 October 2016