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Liaison Estradiol II - Gen (2015-01-15)
- Starting date:
- January 15, 2015
- Posting date:
- January 21, 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-43401
Recalled Products
Liaison Estradiol II - Gen
Reason
Incorrect translation to French in the IFU’s, found in section 15, expected values, the affected languages state 'mean estradiol (pg/ml)' instead of median estradiol (pg/ml) for the normal range data.
Affected products
Liaison Estradiol II - Gen
Lot or serial number
129542XA
130436XA
130578XA
130578XB
131125XA
131416XA
131606XB
Model or catalog number
310680
Companies
- Manufacturer
-
Diasorin Inc.
1951 Northwestern Ave. P.O. Box 285
Stillwater
55082
Minnesota
UNITED STATES