Sight OLO, Automated Hematology Analyzer, Catalog No. OLO-U1
Reported: August 3, 2022 Initiated: June 14, 2022 #Z-1469-2022
Product Description
Sight OLO, Automated Hematology Analyzer, Catalog No. OLO-U1
Reason for Recall
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.
Details
- Recalling Firm
- SIGHT DIAGNOSTICS LTD
- Units Affected
- 72 US; 292 OUS
- Distribution
- 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.
- Location
- Tel Aviv-Yafo
Frequently Asked Questions
What product was recalled? ▼
Sight OLO, Automated Hematology Analyzer, Catalog No. OLO-U1. Recalled by SIGHT DIAGNOSTICS LTD. Units affected: 72 US; 292 OUS.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 3, 2022. Severity: Moderate. Recall number: Z-1469-2022.
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