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Type of Product Medical Device
TGA Recall Reference RC-2015-RN-01017-1
Product Name/Description Synchron Systems Enzymatic Creatinine (CR-E) and Uric Acid (URIC) Reagents. An in vitro diagnostic medical device (IVD)

Product Codes: A60298 (CR-E),

All Lot Numbers are affected

ARTG Numbers: 213984 and 222819
Recall Action Level Hospital
Recall Action Classification Class III
Recall Action Commencement Date 19/10/2015
Responsible Entity Beckman Coulter Australia Pty Ltd
Reason/Issue Beckman Coulter has confirmed that N-Acetyl Cysteine (NAC) used in the treatment of acetaminophen overdose may cause assay interference when administered in therapeutic concentrations with assays using the Trinder chemical pathways; Enzymatic Creatinine (CR-E) and Uric Acid (URIC).

NAC interference may lead to falsely low results for uric acid and creatinine in patients who are concurrently being treated for acetaminophen overdose with NAC.
Recall Action Recall for Product Correction
Recall Action Instructions Beckman Coulter is amending the INTERFERENCES section of the Chemistry Information Sheets to include N-Actel Cysteine. There is no requirement to review previously generated results. This action has been closed-out on 04/03/2016.
Contact Information 1800 060 661 - Customer Support Centre