Database updated: 27 October 2026

Safety Information

Medsafe Online Recall Database

Detail of Recall

Type of Product:Device
Medsafe Reference:23370
Brand Name:Biofire - FilmArray Gastrointestinal (GI) Panel
Model:
Affected:OT-RFIT-ASY-0104 - FilmArray Gastrointestinal GI Panel, 6 pack, OT-RFIT-ASY-0116 - FilmArray Gastrointestinal GI Panel, 30 pack
Software version:
Recalling Organisation:Medi'Ray New Zealand Ltd
53-55 Paul Matthews Road
Albany
Auckland 0632
Contact Information:0800 633 472
Manufacturer:Biomerieux SA
Issue:The manufacturer has recently identified sporadic increases of false positive complaints for the BioFire® FilmArray® Gastrointestinal (GI) Panel, specifically for Yersinia enterocolitica, Vibrio, and Vibrio cholerae.
Recall action type:Correction
Recall action:Manufacturer to issue advice regarding use
Level of recall:Hospital/Pharmacy/Laboratory
Date Commenced:3/8/2018
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