Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 18073 |
| Brand Name: | Biomerieux Vitek 2 Neisseria-Haemophilus Identification Card |
| Model: | Catalogue Number: 416381 |
| Affected: | |
| Software version: | 7.01 |
| Recalling Organisation: | Medi'Ray New Zealand Ltd 53-55 Paul Matthews Road Albany Auckland 0632 |
| Contact Information: | 0800 633 472 |
| Manufacturer: | BioMerieux Inc |
| Issue: | A discrepant inoculum density range has been identified for the Neisseria Haemophilus (NH) Identification (ID) Test Card in the VITEK® 2 7.01 Product Information document (Ref: 514740-1EN1). In Section 6 the documented DensiCHEK™ Plus inoculum density range is 1.80 - 2.20 (this is incorrect). The NH Product Information Culture Requirements Table (Table 47) indicates the DensiCHEK™ Plus inoculum density range to be 2.70 - 3.30 (this is correct). |
| Recall action type: | Correction |
| Recall action: | Instructions for use to be updated |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 19/2/2015 |
