Database updated: 27 October 2026

Safety Information

Medsafe Online Recall Database

Detail of Recall

Type of Product:Device
Medsafe Reference:15571
Brand Name:Vitros Chemistry Products Na+ Slides
Model:8379034
Affected:GENs 7-13
Software version:
Recalling Organisation:Ortho-Clinical Diagnostics c/- Johnson & Johnson
13A Gabador Place
Mt Wellington
AUCKLAND 1060
Contact Information:0800 800 705
Manufacturer:
Brand Name:Vitros Chemistry Products Calibrator Kit 2
Model:1662659
Affected:212 and 292
Software version:
Recalling Organisation:Ortho-Clinical Diagnostics c/- Johnson & Johnson
13A Gabador Place
Mt Wellington
AUCKLAND 1060
Contact Information:0800 800 705
Manufacturer:
Issue:Manufacturer has confirmed that positively biased serum or plasma sample results may occur when using VITROS Na+ slides. The largets bias was obeserved was when using GENs 7-13 when calibrated with VITROS Calibrator Kit Lots 212 and 292.
Recall action type:Recall
Recall action:Product to be returned to supplier
Level of recall:Hospital/Pharmacy/Laboratory
Date Commenced:25/10/2013
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