Print version of this report

Type of Product	Medical Device
TGA Recall Reference	RC-2014-RN-01350-1
Product Name/Description	Enzymatic Creatinine, Cholesterol, Uric Acid, Lactate, and Lipase Assays Enzymatic Creatinine Reference Number: OSR6X204 Cholesterol Reference Number: OSR6X16 Uric Acid Reference Number: OSR6X98 Lactate Reference Number: OSR6X93 Lipase Reference Number: OSR6X30 All lot numbers affected ARTG Number: 200018 In Vitro Diagnostic Medical Devices (IVDs)
Recall Action Level	Hospital
Recall Action Classification	Class I
Recall Action Commencement Date	23/12/2014
Responsible Entity	Beckman Coulter Australia Pty Ltd
Reason/Issue	N-Acetyl Cysteine (NAC), when administered in therapeutic concentrations (for the treatment of acetaminophen overdose), has been recently determined to interfere with the detection of the following analytes on Beckman Coulter clinical chemistry platforms: Enzymatic Creatinine, Cholesterol, Uric Acid, Lactate, and Lipase. NAC is an anti-oxidant and can interfere with assays and this may lead to falsely low results and subsequent mistreatment.
Recall Action	Recall for Product Correction
Recall Action Instructions	The instructions for use will be amended to contain a warning pertaining to patients being treated with N-Acetyl Cysteine (NAC) for a paracetamol overdose may generate false low results for specific tests. This action has been closed-out on 26/08/2016.
Contact Information	1800 060 880 - Customer Support Centre