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Type of Product Medical Device
TGA Recall Reference RC-2013-RN-00337-1
Product Name/Description VIDAS D-Dimer Exclusion II (An in vitro medical device (IVD))

Multiple lot numbers affected

ARTG Number: 190015
Recall Action Level Hospital
Recall Action Classification Class I
Recall Action Commencement Date 30/04/2013
Responsible Entity Biomerieux Australia Pty Ltd
Reason/Issue BioMerieux has received customer complaints regarding non-reproducible results below the detection limit (<45 ng/mL) on the affected lot numbers.
Recall Action Recall for Product Correction
Recall Action Instructions BioMerieux is asking users to repeat testing of results less than 45ng/ml
Contact Information 1800 333 421 - BioMerieux Technical Assistance