Database updated: 3 November 2026

Safety Information

Medsafe Online Recall Database

Detail of Recall

Type of Product:Device
Medsafe Reference:29253
Brand Name:VITEK® 2 GP ID Test Kit
Model:
Affected:21342
Software version:
Recalling Organisation:Medi'Ray New Zealand Ltd
53-55 Paul Matthews Road
Albany
Auckland 0632
Contact Information:0800 633 472
Manufacturer:BioMerieux New Zealand Ltd
Issue:The manufacturer has identified a performance issue associated with the SAC (SACCHAROSE/SUCROSE) reaction during testing of Listeria monocytogenes BAA-751 and the VITEK 2 GP ID test kit. The BAA-751 strain is referenced in the GP ID Package Insert for QC testing. Investigation activities concluded that Listeria monocytogenes BAA-751 may not provide a reliable negative reaction for the SAC well.
Incorrect QC results can potentially lead to a delay in the release of patient results.
Recall action type:Correction
Recall action:Software to be upgraded
Level of recall:Hospital/Pharmacy/Laboratory
Date Commenced:12/4/2022
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