Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 27641 |
| Brand Name: | Access SARS-CoV-2 Antigen assay |
| Model: | |
| Affected: | Multiple lots |
| 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: | As part of an ongoing review of the Emergency Use Authorization (EUA) submission for the Access SARS-CoV-2 Antigen Assay, the FDA requested additional studies which have resulted in a change to the claimed stability conditions for specimens collected in Bartels® FlexTrans™ and Sigma Virocult® transport media. |
| Recall action type: | Correction |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 22/4/2021 |
