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Type of Product Medical Device
TGA Recall Reference RC-2015-RN-00389-1
Product Name/Description Sekisui Diagnostics Acetaminophen Reagent. An in vitro diagnostic medical device (IVD)

List Number: 2K99-20

Lot Number: 45797UQ04
Expiration Date: 30-JUN-2015

Lot Number: 46121UQ07
Expiration Date: 30-SEP-2015

Lot Number: 46561UQ08
Expiration Date: 31-OCT-2015

Lot Number: 46207UQ09
Expiration Date: 30-NOV-2015

Lot Number: 46953UQ12
Expiration Date: 29-FEB-2016
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 7/05/2015
Responsible Entity Abbott Australasia Pty Ltd Diagnostic Division
Reason/Issue The current Instructions for use reports the Interference from N-acetylcysteine (NAC) evaluated on a commercially available analyser. Using a significance criterion of > 10% variance from control, acceptable results were obtained to a level of 800 mg/L N-acetylcysteine (NAC) in a 104 ìg/mL (688 ìmol/L) acetaminophen sample; this in vitro analysis was performed approximately two hours after the addition of NAC to a serum pool.

Based on testing performed by Sekisui Diagnostics on an ARCHITECT cSystems instrument, the concentration of NAC at which acceptable acetaminophen results are obtained is 200 mg/L NAC in values from a 109 ìg/mL acetaminophen sample, tested two hours after the addition of NAC to a serum pool.

The package insert is being updated accordingly based on these results.
Recall Action Recall for Product Correction
Recall Action Instructions Laboratories are advised that treatment with N-acetylcysteine (NAC) could interfere with the assay to a greater extent than previously indicated resulting in negative bias. The Instructions for Use have been updated with this warning. Laboratories are advised to follow their protocols regarding the need for review of previously reported results. This action has been closed-out on 18/04/2017.
Contact Information 1800 816 696 - Abbott Diagnostics