Database updated: 27 October 2026

Safety Information

Medsafe Online Recall Database

Detail of Recall

Type of Product:Device
Medsafe Reference:15663
Brand Name:Biomerieux ZYM B Reagent
Model:70493
Affected:Multiple
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:Biomerieux SA
Brand Name:Biomerieux API NH
Model:10400
Affected:Multiple
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:Biomerieux SA
Brand Name:Biomerieux API Listeria
Model:10300
Affected:Multiple
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:Biomerieux SA
Issue:The manufacturer has identified a vusual defect and activity issue of the ZYM B reagent which is used as an additional test for revealing the results of some miniaturized tests included in API NH and API Listeria. A risk analysis has been done to assess the impact of the ZYM B activity issue on the test results. The investigations concluded that it could lead to misidentificiation of some species with API Strep, API NH, API Listeria and API Coryne.
Recall action type:Recall
Recall action:Product to be destroyed
Level of recall:Hospital/Pharmacy/Laboratory
Date Commenced:14/11/2013
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