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Advia Centaur 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:
- Healthcare Professionals, General Public, Hospitals
- Identification number:
- RA-61954
Affected Products
- Advia Centaur CP System-Progesterone(Prge) Assaye
- Advia Centaur 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
-
Advia Centaur CP System-Progesterone(Prge) Assaye
Lot or serial number
All lots
Model or catalog number
- 01586287
- 02382928
- 118530
- 125362
- 126345
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave
Tarrytown
10591
UNITED STATES
B. Advia Centaur System-Progesterone Assay
Lot or serial number
All lots
Model or catalog number
01586287
02382928
118530
125362
126345
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave
Tarrytown
10591
UNITED STATES