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Type of Product	Medical Device
TGA Recall Reference	RC-2016-RN-00758-1
Product Name/Description	ALT and Glucose-Stat Assays (used for the determination of ALT and Glucose). An in vitro diagnostic medical device (IVD) Reference numbers: ALT OSR6X07, Glucose-Stat OSR6X40 All lots affected ARTG numbers: 200015, 200018
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	10/06/2016
Responsible Entity	Beckman Coulter Australia Pty Ltd
Reason/Issue	Previously unknown drug interferences from Sulfasalazine and Sulfapyridine have been identified. There is a possibility that drug interference's from administration of Sulfasalazine to patients may generate false low ALT results and false low Glucose-Stat results. Sulfapyridine may generate false high Glucose-Stat results (OSR6X40). Interference seen with 300mg/L Sulfasalazine showed a negative bias of up to 35% for the low ALT control and up to 29% for the high ALT control. Interference seen with 300mg/L Sulfasalazine showed a negative bias of up to 25% (or 1.3 mmol/L) for the low Glucose-Stat control and up to 13% (or 1.6mmol/L) for the high Glucose-Stat control. Interference seen with 300mg/L Sulfapyridine showed a positive bias of up to 21% (or 1.1 mmol/L )for the low Glucose-Stat control and up to 9% or (1.1mmol/L) for the high Glucose-Stat control. There is no risk to patients however there is the potential for a delay in results.
Recall Action	Recall for Product Correction
Recall Action Instructions	Beckman Coulter is advising users that the IFU has been updated to include additional warnings in the 'Interfering Substances' section. No retrospective review of results is recommended. This action has been closed-out on 16/03/2018.
Contact Information	1800 060 881 - Beckman Coulter Customer Support Centre