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Type of Product	Medical Device
TGA Recall Reference	RC-2015-RN-01092-1
Product Name/Description	ichem VELOCITY Urine Chemistry Strips. An in vitro diagnostic medical device (IVD). Reference Number: 800-7204 Lot Number: 7204089B ARTG Number: 177551
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	9/11/2015
Responsible Entity	Beckman Coulter Australia Pty Ltd
Reason/Issue	Beckman Coulter has become aware of a manufacturing defect where multiple strips with multiple missing pads were found inside the strip vial for the affected lot number. If the affected strips are used, it may result in quality control failures and potential false negative results for any or all analytes and erroneous pH results if affected strips are used to assay patient samples.
Recall Action	Recall
Recall Action Instructions	Beckman Coulter is advising users to discard affected lots. Any affected lots will be replaced by unaffected product. Beckman Coulter is advising users to consult with the Laboratory Director to determine if a retrospective review of results is clinically warranted. This action has been closed-out on 18/08/2016.
Contact Information	1800 060 881 - Customer Support Centre