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FREE TESTOSTERONE ELISA KIT (2017-09-21)
- Starting date:
- September 21, 2017
- Posting date:
- October 13, 2017
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- Hospitals, General Public, Healthcare Professionals
- Identification number:
- RA-64836
Affected products
FREE TESTOSTERONE ELISA KIT
Reason
Free testosterone ELISA kits, lot 171390, may fail to produce any optical density (OD) values and therefore any results. The low OD values would lead to an inability to meet the QC certificate acceptance criteria. This would result in an invalid test and therefore, no results would be reported.
Affected products
FREE TESTOSTERONE ELISA KIT
Lot or serial number
171390
Model or catalog number
CAN-FTE-260
Companies
- Manufacturer
-
DIAGNOSTICS BIOCHEM CANADA INC.
384 NEPTUNE CRESCENT
London
N6M 1A1
Ontario
CANADA