Access Total T4 Calibrators
- Recalling firm
- Beckman Coulter NZ Ltd
- Product
- Access Total T4 Calibrators. [Device]. Affected: Lots - 538729, 538815, 538898, 539107, 539243
- Reason
- 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.
- Classification
- Class I
- Category
- medical device recall
- Country
- New Zealand
- Agency
- MEDSAFE
- Recall date
- 2026-03-19
- Status
- Ongoing
- Distribution
- New Zealand - Hospital/Pharmacy/Laboratory
Official recall notice from MEDSAFE
Recall details on Nibble Recalls: https://trynibble.app/recalls/5a414504-99b2-4339-83e1-1fdeefd7e20c