Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 27762 |
| Brand Name: | SARS-CoV-2 IgG I |
| Model: | |
| Affected: | All 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: | The manufacturer has identified that the Access SARS-CoV-2 IgG II numerical results for calibrator, quality control (QC), and patient sample values may be multiplied by a factor of 1000 on systems running with the assay protocol file (APF) and access assay file (AAF) versions |
| Recall action type: | Correction |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 19/5/2021 |
