Database updated: 27 October 2026

Safety Information

Medsafe Online Recall Database

Detail of Recall

Type of Product:Device
Medsafe Reference:25512
Brand Name:FTD Respiratory pathogens 21 (FTD-2.1) CE-IVD
Model:
Affected:Update of Instructions for Use concerning the FTD Respiratory pathogens 21 kit
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:This notification follows Field Safety Notification FA-2019-22, "Unsupported Performance Claims for FTD CE-IVD kits" (Medsafe reference: 25484) and provides product-specific information regarding the indicated assays. Under this previous notification, which was a recall, you will have returned all stock.
Recall action type:Correction
Recall action:Instructions for use to be updated
Level of recall:Hospital/Pharmacy/Laboratory
Date Commenced:7/1/2020
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