| TGA Action ID |
RC-2026-RN-00851-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Access HIV Ag/Ab Combo Calibrator. An in vitro diagnostic medical device (IVD).
REF: C39451
Lot Numbers: 472067, 472224, 572049, 572162, 572277, 672059, 672147, 672181 |
| ARTG Number |
462947 |
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Beckman Coulter has determined through internal investigation that the calibrator card 2D barcode for the Access HIV Ag/Ab combo calibrator lot numbers listed above 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.
Approximately 0.029% of patient results generated using the Access HIV Ag/Ab combo Calibrator affected lot numbers may generate false Nonreactive or Reactive Access HIV Ag/Ab combo result interpretations.
This may result in delays in diagnosis and treatment, or patients not being recognised as having HIV infection. |
| Instructions for Customers/Users |
Customers are to:
• Discard all Access HIV Ag/Ab combo Calibrator kits in their laboratory.
• Discontinue using the Access HIV Ag/Ab combo assay until Access HIV Ag/Ab combo calibrator lot number 672285 or higher is available in their laboratory.
• Perform a retrospective review of patient results generated using the affected lots, and evaluate whether retesting is necessary based on available laboratory data. If S/CO values are available, use the tables provided in the customer letter to guide the review.
• Where blood donor claims are applicable, laboratories that do not perform HIV NAT and rely exclusively on Access HIV Ag/Ab combo results for donor eligibility and blood product release should also review Nonreactive results and determine the need for donor follow-up testing at the discretion of the Medical Director.
• Contact their Beckman Coulter representative for replacement product requests and to receive updates on availability and delivery of product unaffected by this problem. |
| Action Commencement Date |
23/10/2026 |
| Responsible Entity |
|
| Contact Information |
1800 060 878 - Beckman Coulter Customer Service |