Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 36673 |
| Brand Name: | Access Total T4 Calibrators |
| Model: | |
| Affected: | Lots - 538729, 538815, 538898, 539107, 539243 |
| 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 Access Total T4 Calibrator may produce erroneously low results on UniCel DxI 600 and UniCel DxI 800 Access Immunoassay Analyzers. Internal testing has determined that calibration curves generated using the Access Total T4 Calibrator may produce quality control and patient results approximately 23% lower than expected on UniCel DxI 600 and UniCel DxI 800 Access Immunoassay Analyzers. Falsely decreased Total T4 results reported to the physician may result in patient misdiagnosis and inappropriate treatment. |
| Recall action type: | Recall |
| Recall action: | Product to be returned to supplier |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 19/3/2026 |
