Product Wiki · Recalls · Health Canada — Medical Devices

Siemens' various Immulite Systems (2017-12-18) — recall 57758

Health Canada — Medical Devices · Canada · 2018-01-08 · Type III

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Agency
Health Canada — Medical Devices
Recall identifier
57758
Date of alert
2018-01-08
Country / jurisdiction
Canada
Risk level
Type III
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: Siemens Healthcare Diagnostics has confirmed through internal investigation that the Immulite/Immulite 1000/Immulite 2000/Immulite 2000 XPI Assays (listed) are susceptible to biotin interference. This occurs when biotin present in patient samples interferes with the Biotin-Streptavidin Assay architecture on the Immulite platform. Biotin interference has the potential to bias analytical results on the assays listed above. The Instructions For Use (IFU) currently do not list biotin as a potential interferant.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/siemens-various-immulite-syste

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