Database updated: 27 October 2026

Safety Information

Medsafe Online Recall Database

Detail of Recall

Type of Product:Device
Medsafe Reference:15361
Brand Name:Panbio Barmah Forest Virus IgM ELISA
Model:Catalogue Number: E-BFV01M / E-BFV01M05
Affected:Lots: 12354, 13051, 13140
Software version:
Recalling Organisation:Abbott Laboratories (NZ) Ltd - Rapid Diagnostics Divison
Ground Floor, Bldg. D
4 Pacific Rise
Mount Wellington
AUCKLAND 1060
Contact Information:0800 466 951
Manufacturer:Alere (Australia)
Issue:The manufacturer has received reports of an increased rate of intermediate-reactive Barmah Forest IgM results in patients who do not go on to seroconvert i.e. false-positive results. Asymptomatic blood donor samples are consistently non-reactive and convalescent samples from confirmed seroconverted patients are consistently highly reactive.
Recall action type:Recall
Recall action:Product to be destroyed
Level of recall:Hospital/Pharmacy/Laboratory
Date Commenced:13/9/2013
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