AMH (Anti-Müllerian Hormone) and Elecsys AMH (2018-04-30)

Starting date:

April 30, 2018

Posting date:

June 14, 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-67022

• Reason
• Affected products

Affected products

A. AMH (Anti-Müllerian Hormone)
B. Elecsys AMH

Reason

The Method Sheet of Elecsys AMH was updated with respect to the Biotin interference declaration in the unit nmol/L. Previously the claim stated incorrectly less or equal to 143 nmol/L; this was corrected to  less or equal to 123 nmol/L. The root cause of this issue was erroneous value transmission to labeling.

Important: The declared value in unit ng/mL was correct at 30 ng/mL and does not need to be changed.
Note: additional minor changes were also applied to the Method Sheet; please refer to the change bars on the right and left text margins for easy change identification.

Affected products