Database updated: 27 October 2026

Safety Information

Medsafe Online Recall Database

Detail of Recall

Type of Product:Device
Medsafe Reference:24992
Brand Name:Tina-quant Soluble Transferrin Receptor (sTFR)
Model:cobas c systems (excl c111)
Affected:
Software version:
Recalling Organisation:Roche Diagnostics (NZ) Ltd
15 Rakino Way
Mt Wellington
AUCKLAND 1644
Contact Information:0800 363 622
Manufacturer:Roche Diagnostics GmbH
Issue:It was observed that the current claim for rheumatoid factors (RF) interference cannot be confirmed for the current STFR assay. Currently, the claim for this assay is that there is no significant interference of RF up to a concentration of 750 IU/mL for cobas c systems. The most recent internal investigations have confirmed that there is no significant interference of rheumatoid factors up to a concentration of 150 IU/mL for cobas c systems.
Recall action type:Correction
Recall action:Instructions for use to be updated
Level of recall:Hospital/Pharmacy/Laboratory
Date Commenced:14/8/2019
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