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Bioflash System Rinse (2014-01-10)
- Starting date:
- January 10, 2014
- Posting date:
- January 24, 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-37641
Recalled Products
- Bioflash System Rinse
Reason
When problematic lots of system rinse are used with the Quanta flash MPO reagents (Catalogue number: 701133), the system is not able to successfully complete calibration and the message "average RLU outside calibration range -50% - 50%" is displayed. The Bioflash cannot proceed to perform a MPO test.
Affected products
A. Bioflash System Rinse
Lot or serial number
- B22718
Model or catalog number
- 3000-8205
Companies
- Manufacturer
-
Inova Diagnostics Inc.
9900 Old Grove Road
San Diego
92131
California
UNITED STATES