| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-00884-1 |
| Product Name/Description |
PREVI Isola System. An in vitro diagnostic medical device (IVD)
Catalogue Numbers: 29500 and 29500R
All lots affected |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
3/09/2012 |
| Responsible Entity |
|
| Reason/Issue |
It has been determined that the PREVI Isola system pipettor may fail to dispense a sample due to the pipettor becoming clogged. The resulting failure to dispense may be caused by all specimen types verified for use with the PREVI Isola system. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Update to Instructions for Use (IFU) and software. |
| Contact Information |
1800 333 421 - BioMerieux Technical Assistance |