Elecsys FT4 III (2018-10-05)

Starting date:

October 5, 2018

Posting date:

November 30, 2018

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-68508

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  Reason
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  Affected products

Affected products

Elecsys FT4 III

Reason

Recall about reduced biotin interference threshold for the recently launched Elecsys FT4 III Assays. The described threshold in the method sheet is less or equal to 409 nmol/l or less or equal to 100 ng/ml of biotin in a sample. However, for the currently available products (lots listed), the threshold is less or equal to 81.8 nmol/l or less or equal to 20 ng/ml (same as previous FT4 II). In patient samples with biotin concentrations of more or equal to 266 nmol/l or more or equal to 65 ng/ml, FT4 recovery could lead to a difference of less than 20%. The overall performance of the Elecsys FT4 III Assays, including the improved robustness against unspecific streptavidin interference, is not impacted (confirmed by the manufacturer).

Affected products