Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 28274 |
| Brand Name: | Inorganic Phosphorus |
| 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: | During internal interference testing, Inorganic Phosphorus failed to meet the hemolytic interference specification for the serum application. The low analyte concentration pool tested (~0.7 mmol/L) exhibited a positive bias with a maximum bias of 24.02% at 3.5 g/L haemolysate. This positive bias is contributed to by phosphorus release from haemolysed cells. Current product labeling reflects only optical interference from haemoglobin and does not account for Inorganic Phosphorus released from haemolysed cells. There is no hemolysis issue with the urine application. |
| Recall action type: | Correction |
| Recall action: | Instructions for use to be updated |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 1/9/2021 |
