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Type of Product	Medical Device
TGA Recall Reference	RC-2016-RN-00065-1
Product Name/Description	iChemVelocity Automated Urine Chemistry System using iChemVelocity Urine Chemistry Strips. An in vitro diagnostic device (IVD) Reference Numbers: 800-7212; 800-7212-001; 800-7204; 800-7204-FJR All Lot and Serial Numbers are affected ARTG Number: 177551
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	3/02/2016
Responsible Entity	Beckman Coulter Australia Pty Ltd
Reason/Issue	There have been complaints indicating that loose or missing analyte pads being found in several locations (strip vial, strip provider module, strip conveyor system or waste container) that are undetectable by the iChemVelocity System. If affected strips are used to assay patient samples, the issue has the potential to cause erroneous pH results and false negative results for the following tests: Nitrite, glucose, blood, bilirubin, urobilinogen, protein, leukocyte esterase, ketones, and ascorbic acid. There is no impact to the measurement of colour, clarity and specific gravity.
Recall Action	Recall
Recall Action Instructions	The sponsor is advising users to discard the vial and not use the strips from that vial when loading strips if loose or missing analyte pads are observed. Users should contact the sponsor for product replacement. A review of patients' results is at the discretion of the laboratory director. This action has been closed-out on 16/02/2017.
Contact Information	1800 060 881 - Beckman Coulter Customer Support Centre