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Glucose-6-Phosphate Dehydrogenase (G-6-PDH)
- Starting date:
- December 29, 2016
- Posting date:
- February 9, 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-62118
Reason
Trinity Biotech has identified a potential for misdiagnosis with lots F117009 and F229031. A recent investigation has identified that these two lots display a level of accuracy variation outside the historical (quality control) QC product release process control charts for normal range controls, despite falling within the QC acceptance specification.
Affected products
Glucose-6-Phosphate Dehydrogenase (G-6-PDH)
Lot or serial number
F229031
Model or catalog number
345-B
Companies
- Manufacturer
-
Trinity Biotech PLC
IDA Business Park
Bray, Wicklow
IRELAND