| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-00909-1 |
| Product Name/Description |
Remel Xpect Clostridium difficile Toxin A/B. An vitro diagnostic medical device (IVD)
R24650 - Lot number: 131988
R24640 - Lot number: 141764 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
6/09/2012 |
| Responsible Entity |
|
| Reason/Issue |
Investigations have confirmed that some units of the reagents in these lots may contain microbial contamination that could impact assay procedure and/or performance. |
| Recall Action |
Recall |
| Recall Action Instructions |
Laboratories to inspect stock and remove from use any units from affected lot numbers. Previous results issued from these lots should be reviewed. |
| Contact Information |
08 8238 9044 - Peter Traynor |