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Type of Product	Medical Device
TGA Recall Reference	RC-2014-RN-00619-1
Product Name/Description	Alere Triage BNP Calibrator for Beckman Coulter Catalogue Number: BS98202 Manufacturer Part Number: 98202 Lot Number: 328163 Expiration Date: 30/09/2014 ARTG Number: 215842
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	6/06/2014
Responsible Entity	Inverness Medical Innovations Australia Pty Ltd T/A Alere
Reason/Issue	The bottle labelled as Calibrator Level 5 actually contains Calibrator Level 4. This results in a calibration failure when attempting to calibrate using a calibrator kit which contains the affected Level 5 Calibrator.
Recall Action	Recall
Recall Action Instructions	Alere is requesting their customers to discontinue use of the affected lot and discard any remaining stock. Replacements will be provided for any unused stock.
Contact Information	07 3363 7711 - Alere Technical Support