Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 26304 |
| Brand Name: | BD MAX™ SARS-CoV-2 Reagent 445003 |
| Model: | |
| Affected: | All Lots |
| Software version: | |
| Recalling Organisation: | Becton Dickinson Pty Ltd 80 Rushdale Street Knoxfield VIC 3180 Australia |
| Contact Information: | |
| Manufacturer: | Becton Dickinson and Company (USA) |
| Issue: | The manufacturer has received reports of potential false positive results when using the BD SARS-CoV-2 Reagents for the BD MAX™ System. A false positive SARS-CoV-2 test result could lead to incorrect triaging for that patient. On review, the manufacturer is revising the User Defined Protocol (UDP) threshold for the N2 target in the Instructions for Use (IFU) from 50 RFU to 80 RFU. |
| Recall action type: | Correction |
| Recall action: | Instructions for use to be updated |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 21/7/2020 |
