Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 16417 |
| Brand Name: | Biomerieux FB Reagent |
| Model: | Reference: 70562 |
| Affected: | All lots |
| 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 |
| Brand Name: | Biomerieux ZYM B Reagent |
| Model: | Ref: 70493 |
| Affected: | All lots |
| 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 |
| Brand Name: | Biomerieux API NH |
| Model: | Ref: 10400 |
| Affected: | All lots |
| 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 |
| Brand Name: | Biomerieux API Listeria |
| Model: | Ref: 10300 |
| Affected: | All lots |
| 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: | During the Quality Control of new lot of FB reagent, a visual defect (colour issue) was observed. The first investigation performed by the manufacturing site showed that this visual defect is due to a specific lot of raw material used for the manufacturing of this FB reagent. In addition, this lot of raw material has also been used for the manufacturing of several lots of FB reagent and ZYM B reagent using the same raw material than the FB reagent. As the involved lots of ZYM B reagent are included inside of API NH and API Listeria kits, the both references are also impacted. |
| Recall action type: | Correction |
| Recall action: | Instructions for use to be updated |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 27/3/2014 |
