Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 28057 |
| Brand Name: | Access SARS-CoV-2 Antigen Assay |
| Model: | |
| Affected: | All lots |
| Software version: | |
| Recalling Organisation: | Beckman Coulter Australia Pty Ltd 1 Dale Street Brookvale NSW 2100 Australia |
| Contact Information: | |
| Manufacturer: | Beckman Coulter Inc |
| Issue: | The manufacturer has determined that the Access SARS-CoV-2 Antigen assay may generate false Reactive interpretations for some nasopharyngeal patient samples. |
| Recall action type: | Recall |
| Recall action: | Product to be destroyed |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 20/7/2021 |
