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QUANTA LYSER SOFTWARE (2015-07-15)
- Starting date:
- July 15, 2015
- Posting date:
- August 10, 2015
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-54548
Affected Products
A. QUANTA LYSER SOFTWARE
Reason
As a result of a complaint and subsequent investigation, a software defect was detected that affects all versions of QUANTA-LYSER software when processing EIA Assays in duplicate only. Results reported from the QUANTA-LYSER using QUANTA link data management software are not affected.
Affected products
A. QUANTA LYSER SOFTWARE
Lot or serial number
VERSION 3.2 AND 3.1
Model or catalog number
- 066QL0171
- 066QL0175
Companies
- Manufacturer
-
Inova Diagnostics Inc.
9900 Old Grove Road
San Diego
92131
California
UNITED STATES