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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 Biomerieux Australia Pty Ltd
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