| 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 |
|
| 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 |