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Type of Product	Medical Device
TGA Recall Reference	RC-2014-RN-00374-1
Product Name/Description	Alere Triage BNP Test for Beckman Coulter (intended to measure B-type Natriuretic Peptide levels) Catalogue Number: BS98200 Lot Number: 331265 ARTG Number: 215842
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	31/03/2014
Responsible Entity	Inverness Medical Innovations Australia Pty Ltd T/A Alere
Reason/Issue	The affected lot may not recover within range when tested using certain commercially available controls. For example, this lot may have lower than expected results when using Bio-Rad's Liquichek Cardiac Marker Plus and Liquichek Cardiac Marker Plus LT controls. This lot may also have higher than expected results when using Thermo Scientific MAS Cardiolmmune XL Controls.
Recall Action	Recall for Product Correction
Recall Action Instructions	Alere is alerting their customers to the issue and advising that the affected lots should only be used with Alere Triage BNP QC Controls. It is also recommended that all borderline control and patient results are repeated using an alternative method.
Contact Information	07 3363 7711 - Alere Technical Support