Database updated: 27 October 2026

Safety Information

Medsafe Online Recall Database

Detail of Recall

Type of Product:Device
Medsafe Reference:28465
Brand Name:MYO2, Tina-quant Myoglobin Gen. 2
Model:
Affected:Product code - 08252629190
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:The manufacturer received one customer complaint alleging discrepant results with the Myoglobin test during method comparison between cobas c 503 and cobas c 501. A low bias was observed with QC and patient samples on cobas c 503.
Recall action type:Correction
Recall action:Instructions for use to be updated
Level of recall:Hospital/Pharmacy/Laboratory
Date Commenced:13/10/2021
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