Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 26010 |
| Brand Name: | VITEK® 2 Systems Software Version |
| Model: | |
| Affected: | Software Version 9.01/9.02 release. |
| Software version: | |
| Recalling Organisation: | Medi'Ray New Zealand Ltd 53-55 Paul Matthews Road Albany Auckland 0632 |
| Contact Information: | 0800 633 472 |
| Manufacturer: | BioMerieux Inc |
| Issue: | The manufacturer has identified three (3) errors identified in the associated VITEK® 2 Systems Software Version 9.02 Release Notes (Version 2) that you received with your 9.01/9.02 update kit. The lack of Proteus mirabilis in this rule will unnecessarily suppress cza02n results from reporting for this species. As the indications for use apply to FDA-cleared tests only, this will only affect customers using the CLSI parameter set that want to follow the strict FDA Indications for Use. |
| Recall action type: | Correction |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 7/5/2020 |
