Database updated: 27 October 2026

Safety Information

Medsafe Online Recall Database

Detail of Recall

Type of Product:Device
Medsafe Reference:24874
Brand Name:Ferritin (FERR) Reagent
Model:
Affected:Lot - EA9227
Software version:
Recalling Organisation:Siemens Healthcare (NZ) Ltd
Millennium Centre, Part Level 2, Building A
600 Great South Road
Ellerslie
AUCKLAND 1051
Contact Information:0800 310 300
Manufacturer:Siemens Healthcare Diagnostics Inc
Issue:The manufacturer has confirmed that the Dimension Ferritin (FERR) Flex reagent may exhibit a negative bias during the open well stability time period. It was determined that FERR values can potentially decrease by -50% at a concentration of 22 µg/L and -48% at a concentration of 285 µg/L after a 10 day open well period. It was also determined that FERR values can potentially decrease by approximately -15% after a 3 day open well period. Quality control and patient samples are affected similarly.
Recall action type:Recall
Recall action:Product to be destroyed
Level of recall:Hospital/Pharmacy/Laboratory
Date Commenced:22/7/2019
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