Elecsys Calcitonin (2019-10-07)

Starting date:

October 7, 2019

Posting date:

November 1, 2019

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type III

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-71467

Last updated: 2019-11-01

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  Reason
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  Affected products

Affected Products

Elecsys Calcitonin

Reason

The manufacturer performed drug interference testing and confirmed that an influence on recovery was found for itraconazole on Elecsys Calcitonin assays. The method sheets will be revised to include a disclaimer in the limitation-interference section.

Affected products