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Quanta Lite h-tTG IgG Elisa (2014-02-17)
- Starting date:
- February 17, 2014
- Posting date:
- April 4, 2014
- 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-38657
Recalled products
- Quanta Lite h-tTG IgG Elisa
Reason
The low positive control included in the kit can fail to generate sufficient reaction to meet the minimum optical density required by the direction insert. This would result in an invalid test and therefore, no results would be reported. Any results already reported with acceptable QC criteria are not impacted by this recall.
Affected products
A. Quanta Lite h-tTG IgG Elisa
Lot or serial number
- 004311
Model or catalog number
- 708755
Companies
- Manufacturer
-
Inova Diagnostics Inc.
9900 Old Grove Road
San Diego
92131
California
UNITED STATES