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Software for LifeCycle for Prenatal Screening (2015-05-25)
- Starting date:
- May 25, 2015
- Posting date:
- June 12, 2015
- 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-53767
Recalled Products
A. Software for LifeCycle for Prenatal Screening
Reason
Manufacturer has become aware that lifecycle for prenatal screening (5014-0020) may generate an incorrect risk calculation result for twins.
Affected products
A. Software for LifeCycle for Prenatal Screening
Lot or serial number
v4.0
v4.0 Rev. 2
v4.0 Rev. 3
Model or catalog number
5014-0020
Companies
- Manufacturer
-
Wallac Oy
Mustionkatu 6, P.O. Box 10
Turku
20750
FINLAND