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QUANTA FLASH DFS70 (2016-08-15)
- Starting date:
- August 15, 2016
- Posting date:
- August 26, 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-59990
Affected Products
QUANTA FLASH DFS70
Reason
Upon investigation into complaints from customers, Inova Diagnostics, Inc has confirmed that control values for the affected lot 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
161012
161013
Model or catalog number
701268
Companies
- Manufacturer
-
Inova Diagnostics Inc.
9900 Old Grove Road
San Diego
92131
California
UNITED STATES