Product Wiki · Recalls · Health Canada — Medical Devices

Various Siemens Dimension Systems (2017-10-20) — recall 57537

Health Canada — Medical Devices · Canada · 2017-10-30 · Type III

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Agency
Health Canada — Medical Devices
Recall identifier
57537
Date of alert
2017-10-30
Country / jurisdiction
Canada
Risk level
Type III
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Notice status
Archived by the issuing authority — kept for reference
Reported risk: The biotin concentration in the non-interfering table for dimension FT4L and TSHL and Dimension Vista TSH is incorrect and the biotin concentration is being revised. In addition, Dimension Vista CTNI and MMB and Dimension SIRO do not indicate biotin interference in the non-interfering table of the IFU. The IFU will be updated with the established claim for biotin.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/various-siemens-dimension-syst

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