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Type of Product	Medical Device
TGA Recall Reference	RC-2013-RN-00388-1
Product Name/Description	Elecsys Beta-CrossLaps. An in vitro diagnostic medical device (IVD) Material number: 11972308122
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	3/05/2013
Responsible Entity	Roche Diagnostics Australia Pty Limited
Reason/Issue	Roche is revising the package insert claims for the sample stability (serum and heparinised plasma) and biotin interference of Elecsys Beta-CrossLaps. The package insert will be updated to reflect the results of recent internal testing for sample stability testing and biotin interference as follows: - The sample stability claim for serum kept at 20-25 degrees Celcius will be revised from 8 hours to 6 hours - The sample stability claim for heparinised plasma kept at 20-25 degrees Celcius will be revised from 24 hours to 4 hours - The sample stability claim for heparinised plasma kept at 4-8 degrees Celcius will be revised from 24 hours to 8 hours. - The biotin interference claim "The assay should be unaffected by biotin up to 368nmol/L or 90 ng/mL" will be revised to "The assay should be unaffected by biotin up to 123nmol/L or 30ng/mL".
Recall Action	Recall for Product Correction
Recall Action Instructions	Roche Diagnostics are providing updated information that reflects the results of recent internal testing. A package insert update will include these changes from August, 2013.
Contact Information	1800 645 619 - Roche Diagnostics National Support Centre