Sight OLO, Automated Hematology Analyzer, Catalog No. OLO-U1
Recall
- Recall Number
- Z-1469-2022
- Event Number
- 90533
- Firm
- SIGHT DIAGNOSTICS LTD 23, Derekh Menakhem Begin Tel Aviv-Yafo Israel
- FEI Number
- 3016099075
- Product Code
- GKZ
- Status
- Open, Classified
- Root Cause
- Software Design Change
- Initiated
- June 14, 2022
Description
Sight OLO, Automated Hematology Analyzer, Catalog No. OLO-U1
The default reference ranges for MCH, MCHC, and RDW for age group "Child 2-11y" are mixed up and incorrectly displayed on OLO devices running software version 2.63, 2.63.1, and 2.63.1.1. Due to the issue, results may incorrectly appear to be within or outside the reference range.
On June 14, 2022, the firm notified customers via email of the recall. Customers were informed that a software correction for this issue will be included in any software version ABOVE 2.63.1.1. Pending the software correction through a version upgrade, the firm provided instructions to manually configure the correct default reference ranges on the device, which are also included in Section 2.5.4 of the Sight OLO Operator's Manual. Alternatively, you can contact [email protected] and coordinate a time for Sight's technical support team to remotely update your device software.
Worldwide distribution - US Nationwide distribution in the states of Alabama, Arizona, California, Florida, Idaho, Illinois, Kansas, Kentucky, Massachusetts, Michigan, Minnesota, Mississippi, New Jersey, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin and the countries of Burkina Faso, Belize, Canada, Cote D'Ivoire, Cameroon, Curacao, Germany, Spain, Finland, United Kingdom, Greece, Hong Kong, Indonesia, Ireland, Israel, India, Italy, Mexico, Portugal, Qatar, Sweden, Slovenia, Chad, Thailand, South Africa.
72 US; 292 OUS