Health product recall

Immulite 2000 Sytstem Thyroglobulin Assay

Last updated

Summary

Product
Immulite 2000 Sytstem Thyroglobulin Assay
Issue
Medical devices - Labelling and packaging
What to do

Contact the manufacturer if you require additional information. 

Affected products

Affected products Lot or serial number Model or catalogue number
Immulite 2000 Sytstem Thyroglobulin Assay 436 431 433 434 L2KTY2

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

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Chemistry
Companies

Siemens Healthcare Diagnostics Products Limited

Glyn Rhonwy, Llanberis, Gwynedd, Great Britain, LL55 4EL

Published by
Health Canada
Audience
General public
Healthcare
Industry
Recall class
Type II
Identification number
RA-72403