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