| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00834-1 |
| Product Name/Description |
Fluoprep (Mounting medium for immunofluorescence microscopy) - An in vitro diagnostic medical device (IVD).
Reference: 75521
Lot number: 1001818920
Expiry date: 28/11/2013 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
9/08/2013 |
| Responsible Entity |
|
| Reason/Issue |
bioMerieux has advised that some units in lot 1001818920 of Fluoprep (reference 75521) may be to too thick and is difficult or impossible to spread on the slide. |
| Recall Action |
Recall |
| Recall Action Instructions |
End users are requested to discard any product that is too thick to effectively use and contact bioMerieux to organise for replacement stock. |
| Contact Information |
1800 333 421 - bioMerieux Australia Technical Assistance |