Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 19787 |
| Brand Name: | bioMerieux VIDAS TOXO IgM |
| Model: | 30202 |
| Affected: | multiple lot numbers |
| Software version: | |
| Recalling Organisation: | Medi'Ray New Zealand Ltd 53-55 Paul Matthews Road Albany Auckland 0632 |
| Contact Information: | 0800 633 472 |
| Manufacturer: | Biomerieux SA |
| Issue: | Following a complaint from a customer related to discrepant results observed when testing heat inactivated sera, bioMérieux performed an investigation concluding that the performance of VIDAS TOXO IgM kit using heat inactivated sera (56°C for 30 minutes) is not in accordance with the performance characteristics as stated in the IFU. The investigation confirmed that the index results obtained with inactivated sera are lower compared to values obtained with fresh sera and may result in false negative results. |
| Recall action type: | Correction |
| Recall action: | Product to be returned to supplier |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 26/2/2016 |
