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Type of Product	Medical Device
TGA Recall Reference	RC-2018-RN-00254-1
Product Name/Description	PTS Panels CHOL+GLU test strips. An in vitro diagnostic medical device (IVD) Reference Number: 1765 Lot Number: A705 and A707 Expiry Date: August 2018 Unique Device Identification Code: Lot Numbers: A705: (01)00381931765016(17)180813(10)A705 Lot Numbers: A707: (01)00381931765016(17)180828(10)A707 ARTG Number: 252292 (Point Of Care Diagnostics Australia - Clinical chemistry substrate IVDs)
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	27/03/2018
Responsible Entity	Point Of Care Diagnostics Australia Pty Ltd
Reason/Issue	This recall is being conducted due to the potential for loss of activity of the glucose analyte prior to the full stated shelf life (August 2018). Based on the results of internal testing, there is potential for under-recovery of the glucose analyte, and therefore, potential for lower glucose test results. This issue may result in the delay in diagnosis of diabetes. There have been no adverse events reported in conjunction with this product
Recall Action	Recall
Recall Action Instructions	Point of Care Diagnostics (PTS) is advising users to inspect stock and quarantine any remaing kits of the affected lots. Affected stock is to be destroyed. PTS will issue replacement product or a credit note. This action has been closed out on the 26/11/2018.
Contact Information	1800 640 075 - Point of Care Diagnostics