Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 28447 |
| Brand Name: | Glucose reagent OSR6x21 |
| Model: | |
| Affected: | All lots |
| Software version: | |
| Recalling Organisation: | Beckman Coulter NZ Ltd Suite 2, Level 4 30 St Benedicts Street Newton AUCKLAND |
| Contact Information: | 0800 446 109 |
| Manufacturer: | Beckman Coulter Inc |
| Issue: | The manufacturer has determined that the Glucose Haemolysate application did not consistently meet the current haemolytic interference claim i.e. interference less than 20% up to 150 g/L haemoglobin. The low analyte concentration pool exhibited a maximum negative bias of -21.24% at 150 g/L haemoglobin. |
| Recall action type: | Correction |
| Recall action: | Instructions for use to be updated |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 8/10/2021 |
