QUANTA-Lyser 3000 (2019-04-21)
- Starting date:
- April 21, 2019
- Posting date:
- June 14, 2019
- 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-70193
Last updated: 2019-06-14
Affected Products
QUANTA-Lyser 3000
Reason
The communication cable dongle (item # 23485046) packaged with the device, in isolated cases may lead to communication interruption and consequently abort the process. This will in turn require the operator to start over and repeat the testing as no test results would have been generated.
Affected products
QUANTA-Lyser 3000
Lot or serial number
Not applicable.
Model or catalog number
066VS3000
Companies
- Manufacturer
-
Inova Diagnostics Inc.
9900 Old Grove Road
San Diego
92131
California
UNITED STATES