Elecsys DHEA-S (2018-01-05)

Starting date:

January 5, 2018

Posting date:

January 29, 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-65836

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  Reason
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  Affected products

Affected products

Elecsys DHEA-S

Reason

The method sheet of Elecsys DHEA-S for Cobas E411, Cobas E601, Cobas E602 and modular analytics E systems has been updated for several changes and the revised method sheet now contains the following information: no interference was observed from rheumatoid factors up to a concentration of 80 IU/ml.

Affected products