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Specimen Gate Laboratory
- Starting date:
- March 7, 2017
- Posting date:
- March 24, 2017
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- Healthcare Professionals, General Public, Hospitals
- Identification number:
- RA-62790
Reason
There is a possibility that incorrect neonatal screening results could be reported incorrectly due to unintended change of data related to the manually calculated assays in specimen gate laboratory software.
Affected products
Specimen Gate Laboratory
Lot or serial number
1.3 Rev 2
1.8
1.9
1.9 Rev 2
Model or catalog number
5002-0180
Companies
- Manufacturer
-
Wallac Oy
Mustionkatu 6, P.O. Box 10
Turku
20750
FINLAND