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QUANTA FLASH DFS70 (2016-04-23)
- Starting date:
- April 23, 2016
- Posting date:
- May 16, 2016
- 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-58366
Affected products
- QUANTA FLASH DFS70
Reason
Control values for lot 151011 of QUANTA Flash DFS70 fell below the acceptable range. When control values fall outside of the acceptable range, the run is considered invalid. Results from an invalid run cannot be reported and the run needs to be repeated.
Affected products
-
QUANTA FLASH DFS70
Lot or serial number
- 151011
Model or catalog number
- 701268
Companies
- Manufacturer
-
Inova Diagnostics Inc.
9900 Old Grove Road
San Diego
92131
California
UNITED STATES