| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00174-1 |
| Product Name/Description |
TREPANOSTIKA TP Recombinant Kit (An in vitro diagnostic medical device (IVD) used for the qualitative determination of specific antibodies to Syphilis (treponema pallidum) in human serum or plasma)
Product Code: 285035
Lot: D33GA
Expiry: 2013-07-28 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
25/02/2013 |
| Responsible Entity |
|
| Reason/Issue |
Following customer complaints on out of range negative control, bioMérieux investigation has confirmed an issue with some lots of TREPANOSTIKA™ TP recombinant related to the aluminium bag that contains the microelisa strip plates. The impacted strips may contain bad aluminium bags, or a mixture of
good and bad aluminium bags. As a result, customers may either experience false results or negative control out of range. |
| Recall Action |
Recall |
| Recall Action Instructions |
Biomereiux is asking customers to stop using the affected lot and discard them. |
| Contact Information |
1800 333 421 - Biomerieux Australia Technical Assistance |