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Health Canada Medical devices

Immulite 2000 Sytstem Thyroglobulin Assay

Issued January 5, 2023
Issue
Siemens Healthcare Diagnostics Inc. has confirmed through customer complaints the potential for functional sensitivity to not meet instructions for use (IFU) claims with the kit lots listed in table 1. Additionally, immulite thyroglobulin control module control level one may result outside of the published ranges. Per good laboratory practice, patient results are not reported when controls result out of range. Recall start date: December 15, 2022
Hazard description
Labelling and packaging
Product
Product name
Immulite 2000 Sytstem Thyroglobulin Assay
Reference
ID
RA-72403