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Pregnansee
- Starting date:
- June 6, 2016
- Posting date:
- February 1, 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-62042
Reason
Substantial percentage of tests do not provide a functioning result, a clear reading or the control window remains blank therefore resulting in a defective test and an inconclusive pregnancy result.
Affected products
Pregnansee
Lot or serial number
1120315
Model or catalog number
EARLYPRG
EARLYPRGX2
Companies
- Manufacturer
-
MANSFIELD MEDICAL DISTRIBUTORS LTD.
5775 ANDOVER
MONTREAL
H4T 1H6
Quebec
CANADA