Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 21145 |
| Brand Name: | ETEST® XM256 (Cefuroxime) |
| Model: | |
| Affected: | ETEST XM256 (Cefuroxime) WW SPB lot number1002884720, ETEST XM256 (Cefuroxime) WW SPB lot number 1003383650, ETEST XM256 (Cefuroxime) WW Foam lot number 1003075850, ETEST XM256 (Cefuroxime) WW Foam lot number 1003385930 |
| 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: | Investigation confirmed a potential performance issue on strain categorization for Streptococcus pneumoniae and for Enterobacteriaceae strains limited to oral cefuroxim breakpoints and based on 2016 CLSI clinical standards only. For Streptococcus pneumoniae on ETEST® XM256 (Cefuroxime) FOAM and SPB could lead to minor error on clinical strains: o False Susceptible result instead of Intermediate results with BMD (Broth Micro Dilution) reference method o False Intermediate result instead of Resistant results with BMD reference method For Enterobacteriaceae on ETEST® XM256 (Cefuroxime) FOAM and SPB could lead to minor error on clinical strains: o False Susceptible result instead of Intermediate results with AD (Agar Dilution) reference method o False Intermediate result instead of Resistant results with AD reference method |
| Recall action type: | Correction |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 23/2/2017 |
