Elecsys T3 (2018-02-28)

Starting date:

February 28, 2018

Posting date:

March 23, 2018

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-66262

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  Reason
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  Affected products

Affected products

ELECSYS T3

Reason

Following an internal investigation, the Elecsys T3 Assay (cat # 07027869190) will need to have a correction of the unit of measure for the cross-reactant rt3 value included in the method sheet of the cobas e810 module (corrected from ug/dl to ug/ml).

Affected products