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DIASTAT Ana
- Starting date:
- February 17, 2017
- Posting date:
- April 4, 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-62906
Reason
Testing of retain material at Euro Diagnostica and a sample panel from healthy donors showed that there was an increased risk for equivocal sample results with the lot TS 2076, which showed a malfunction.
Affected products
DIASTAT Ana
Lot or serial number
TS 2076
Model or catalog number
Not Applicable
Companies
- Manufacturer
-
Euro-Diagnostica AB
Lundavagen 151
Malmo
21224
SWEDEN