Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 26000 |
| Brand Name: | IMMAGE Immunochemistry Systems |
| Model: | C3, C4, HPT, IGA, and IGM Reagents; PNs 446450, 446490, 446480, 446460, 447610 |
| Affected: | |
| 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 identified that the following chemistries fail to meet IFU interference claims at high levels of Lipid (Triglycerides): C3 at 1000 mg/dL, C4 at 500 mg/dL, HPT at 750 mg/dL, IGA at 1000 mg/dL and IGM at ?250 mg/dL. |
| Recall action type: | Correction |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 1/9/2020 |
