Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 19666 |
| Brand Name: | Bio-Merieux API ZYM B reagent |
| Model: | 70493 |
| Affected: | Lot Nos: 100375610, 1003772410, 1003772470, 100387970, 1003790030, 1004077210, 1004097610, 1004355410 and 1004355730 |
| Software version: | |
| Recalling Organisation: | Medi'Ray New Zealand Ltd 53-55 Paul Matthews Road Albany Auckland 0632 |
| Contact Information: | 0800 633 472 |
| Manufacturer: | BioMerieux Australia Pty Ltd |
| Issue: | A customer reported a false negative result with Streptococcus group D strain using reagent API ZYM B. Customer retested the S,pyogenes strain on diferent lots and no colour changes were detected. Manufacturer's investigaton confirmed a loss of performance due to light exposure after 3 months of shelf life for API ZYM B which lead to false negative results on some API strups. |
| Recall action type: | Correction |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 18/1/2016 |
