Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 27365 |
| Brand Name: | PANTHER FUSION TUBE TRAYS |
| Model: | |
| Affected: | PRD-04000 (FAB-15004 - Each box of PRD-04000 (FAB-15004) contains 18 Tube Trays, 56 tubes per tray |
| Software version: | |
| Recalling Organisation: | Hologic (Australia and New Zealand) Pty Ltd c/o Logical Freight Solutions NZ Ltd Unit 8/113 Pavilion Drive Airport Oaks Auckland 2022 |
| Contact Information: | |
| Manufacturer: | Hologic Inc |
| Issue: | The manufacturer has recently identified specific lots of tube trays that have a low risk of leaking, that could potentially result in false positive results, false negative results, or invalid patient results or assay worklists, in the Panther Fusion assays (SARS-CoV-2, Flu A/B/RSV, Paraflu, AdV/hMPV/RV, Bordetella, MRSA and GBS) and In-house IVDs using the Open Access functionality of the Panther Fusion system. |
| Recall action type: | Recall |
| Recall action: | Product to be returned to supplier |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 2/3/2021 |
