Database updated: 27 October 2026

Safety Information

Medsafe Online Recall Database

Detail of Recall

Type of Product:Device
Medsafe Reference:27784
Brand Name:Trinity NMT Syphilis IgM ELISA
Model:
Affected:Lot numbers - 125 (expiry 28/06/2022)
Software version:
Recalling Organisation:Banksia Scientific Pty Ltd (NZ)
12 Brigade Street
Airport Oaks
Auckland
Contact Information:09 921 2626
Manufacturer:Trinity Biotech
Issue:The manufactuer has become aware of a labelling issue within CaptiaTM NMT Syphilis IgM 2329360 lot 125 (expiry 28/06/2022). The kit controls are mislabelled with the label for the positive control on the negative control and the label for the negative control on the positive control. The manufacturer's inspection of remaining inventory indicated that the entire lot of CaptiaTM NMT Syphilis IgM 2329360 lot 125 is impacted.
Recall action type:Recall
Recall action:Product to be returned to supplier
Level of recall:Hospital/Pharmacy/Laboratory
Date Commenced:24/5/2021
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