Database updated: 27 October 2026

Safety Information

Medsafe Online Recall Database

Detail of Recall

Type of Product:Device
Medsafe Reference:14250
Brand Name:BioMerieux Vitek 2 System/ Vitek 2 Compact System
Model:W0452,413642, 413862, W0449, W0447, W0441, W0438, 410615, 413861, 413411 and 27685.
Affected:
Software version:
Recalling Organisation:BioMerieux New Zealand Ltd
Suite 4, The Business Connection Office
2 Kalmia Street
Auckland 1544
Contact Information:0800 284 825
Manufacturer:
Issue:Under specific conditions the Vitek 2 and Vitek 2 Compact PC systems connected to a Laboratory Information System (LIS) have the potertial to link a test result to an incorrect patient record.
The four coditions required to potentially cause an occurence of this issue are:
Patient Demographics option is enabled
Pateint demographics are not associated with the isolate
User does not resolve Qualified isolates
Laboratory re-uses Lab IDs (accession numbers) prior to Qualified isolates being resolved.
Recall action type:Correction
Recall action:Instructions for use to be updated
Level of recall:Hospital/Pharmacy/Laboratory
Date Commenced:22/2/2013
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