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Immulite System- IGF-1 (Insulin like Growth Hormone) — recall 57732

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

As described by Health Canada — Medical Devices: Immulite System- IGF-1 (Insulin like Growth Hormone) - 1000 and 2000 Assay (2017-11-30)

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Agency
Health Canada — Medical Devices
Recall identifier
57732
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: In response to customer feedback, Siemens evaluated alternate statistical methods to determine if an alternate method would be a better fit for the reference range data published in the Information for Use (IFU). Our investigation concluded that the LMS method provided a better fit to the data and produced ranges more consistent with the expected physiological change in IGF-I levels compared to use of the weighted average results reported in the IFU.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/immulite-system-igf-1-insulin-

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