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Dimension Vista System-Loci Progesterone Assay (Prog) Assay
- 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-61970
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
Dimension Vista System-Loci Progesterone Assay (Prog) Assay
Lot or serial number
All lots
Model or catalog number
- K6464
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
500 GBC DRIVE, MAILSTOP 514, P.O. BOX 6101
Newark
19714-6101
Delaware
UNITED STATES