Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 22243 |
| Brand Name: | VITEK 2 Gram Positive- ID Card |
| Model: | |
| Affected: | VITEK® 2 GP ID Lots #2420192403, 2420198203 |
| 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: | An internal investigation has confirmed, occurrences of atypical negative O129R reactions for Enterococcus casseliflavus ATCC® 700327™ in association with three(3) VITEK® 2 GP ID, causing failure of the Quality Control (QC) testing for the VITEK® 2 GP ID card. In accordance with the VITEK® 2 GP ID Instructions For Use, the expected O129R reaction for ATCC® 700327™ strain is positive. As a precaution, the manufacturer is also including in the scope of this notice all GP ID card lots manufactured with the same raw materials |
| Recall action type: | Recall |
| Recall action: | Product to be destroyed |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 10/11/2017 |
