| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-00702-3 |
| Product Name/Description |
Premier C. difficile GDH - Positive Control Lot 6088.011, (Enzyme Immunoassay kit for the detection of C. difficile antigen (GDH)); An in vitro diagnostic medical device (IVD)
Catalogue Number: 611096
Lot Number: 611096C013
Expiration Date: 2013-04-28 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
12/07/2012 |
| Responsible Entity |
|
| Reason/Issue |
The manufacturer has received reports from customers that the positive Control reagent is producing values close to or below the specified cut off of equal to or greater than 0.600, particularly when using automated instrumentation. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Quarantine and dispose of any remaining affected product appropriately. |
| Contact Information |
02 9209 4763 - Bioline Technical Service |