Health product recall

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

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

A. AMH (Anti-Müllerian Hormone)

Lot or serial number

All lots.

Model or catalog number

06331076190

Companies
Manufacturer

Roche Diagnostics GMBH

Sandhoferstrasse 116

Mannheim

68305

GERMANY

B. Elecsys AMH

Lot or serial number

All lots.

Model or catalog number

07026714190

Companies
Manufacturer

Roche Diagnostics GMBH

Sandhoferstrasse 116

Mannheim

68305

GERMANY