Immulite System Progesterone Assays (2017-01-06)

Starting date:

January 6, 2017

Posting date:

January 25, 2017

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-61968

• Reason
• Affected products

Affected Products

1. Immulite 100 System-Progesterone Assay
2. Immulite 2000 System-Progesterone Assay
3. Immulite System-Progesterone Assay

Reason

Siemens has confirmed that the presence of DHEA-S (a metabolite of DHEA, a steroid hormone that may be used as part of in vitro fertilization (IVF) protocols to improve ovarian response and IVF treatment outcomes) causes falsely elevated progesterone results on the ADVIA Centaur, Dimension Vista and Immulite Systems around the clinically important decision level of approximately 1 ng/ml (3.18 nmol/l) of progesterone. This threshold is used by some IVF protocols to determine whether to proceed with fresh embryo transfer in the current cycle.

Affected products