Print version of this report
Type of Product Medical Device
TGA Recall Reference RC-2012-RN-01232-1
Product Name/Description MagNA Pure 96. An in vitro diagnostic medical device (IVD)
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 6/12/2012
Responsible Entity Roche Diagnostics Australia Pty Limited
Reason/Issue Due to a software malfunction, the MagNA Pure 96 system may not refill the internal system fluid reservoir before and during the load check at the beginning of a run.
Recall Action Recall for Product Correction
Recall Action Instructions Roche is providing work around instructions for users to implement.
Contact Information 1800 645 619 - Roche National Support Centre