Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 25484 |
| Brand Name: | FTD CE-IVD Kits |
| Model: | |
| Affected: | All lots |
| Software version: | |
| Recalling Organisation: | Banksia Scientific Pty Ltd (NZ) 12 Brigade Street Airport Oaks Auckland |
| Contact Information: | 09 921 2626 |
| Manufacturer: | Siemens Healthcare Diagnostics Inc |
| Issue: | Update information: investigation has confirmed that for identified products, various performance claims listed in the current Instructions for Use will not be met (i.e. sensitivity, specificity, LoD, etc.). This creates the potential for increased instances of erroneous results (false positives, false negatives, etc.) and confirms a previously unidentified risk to patient health, starting with the date when these kits were first made available |
| Recall action type: | Recall |
| Recall action: | Product to be destroyed |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 3/2/2020 |
