| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00342-1 |
| Product Name/Description |
Streptex Group D Latex agglutination reagent R30950901, An in vitro diagnostic medical device (IVD)
Lot number: 1149576 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
19/04/2013 |
| Responsible Entity |
|
| Reason/Issue |
Investigations by the manufacturer have confirmed that latex reagent within this batch may give weak or false negative results. Continued use of this lot could result in false negative results with some cultures. |
| Recall Action |
Recall |
| Recall Action Instructions |
Oxoid is asking customers to destroy the affected reagents. |
| Contact Information |
08 8238 9044 - Oxoid Australia Regulatory Affairs |