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Type of Product	Medical Device
TGA Recall Reference	RC-2015-RN-00671-1
Product Name/Description	iChemVELOCITY Automated Urine Chemistry System using iChemVELOCITY Urine Chemistry Strips Strip part numbers 800-7204 and 800-7204-001
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	21/07/2015
Responsible Entity	Beckman Coulter Australia Pty Ltd
Reason/Issue	The iChemVELOCITY systems do not maintain the on-board strip stability claim of 10 days at 18-28 degrees Celsius at 20-80% relative humidity (RH) as stated in the iChemVELOCITY product labelling. The on-board strip stability is affected by temperature and humidity in your laboratory. Test results may be affected as indicated below: False low or false negative results: Ketone, Blood False high or false positive results: Bilirubin, Urobilinogen, Glucose, Nitrite False high results: Leukocytes Ascorbic Acid, Protein and pH are not affected.
Recall Action	Recall for Product Correction
Recall Action Instructions	Beckman Coulter is providing an updated stability guide and additional handling instructions to ensure the stability of the test strips. The manufacturer, Iris International, has determined that the Strip Provider Module is not maintaining the humidity levels associated with the original on-board strip stability claim and is urgently developing a corrective action. This action has been closed-out on 06/09/2016.
Contact Information	1800 060 881 - Customer Support Centre