Health product recall

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