Access Hiv Ag/ab Combo Calibrator
- Recalling firm
- Beckman Coulter NZ Ltd
- Product
- Access HIV Ag/Ab Combo Calibrator. [Device]. Model: Ref #C39451. Affected: Multiple lots
- Reason
- The manufacturer has determined through internal investigation that the calibrator card 2D barcode for the Access HIV Ag/Ab combo calibrator contain reversed assay calibrator value assignments. As a result, the DxI 9000 Access Immunoassay Analyzer attributes the HIV-Ag calibrator assigned values to the HIV-Ab assay, and the HIV-Ab calibrator assigned values to the HIV-Ag assay., Access HIV Ag/Ab combo Calibrator may generate false Nonreactive or Reactive Access HIV Ag/Ab combo result interpretations.
- Classification
- Class I
- Category
- medical device recall
- Country
- New Zealand
- Agency
- MEDSAFE
- Recall date
- 2026-10-22
- Status
- Ongoing
- Distribution
- New Zealand - Hospital/Pharmacy/Laboratory
Official recall notice from MEDSAFE
Recall details on Nibble Recalls: https://trynibble.app/recalls/d29ff85d-d9a7-4972-a641-ac133b7c8719