Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 24532 |
| Brand Name: | IMMAGE Immunochemistry Systems Immunoglobulin M (IGM) Reagent |
| Model: | |
| Affected: | IGM reagent lots M803185 and M806164 |
| 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 patient samples tested with IGM reagent lots M803185 and M806164 may generate E60 (No Reaction, Antigen Excess Failed) or E66 (Unstable Reaction) error messages on very low concentration samples. |
| Recall action type: | Recall |
| Recall action: | Product to be destroyed |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 2/5/2019 |
