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Open, Classified

Sight OLO, Automated Hematology Analyzer, Catalog No. OLO-U1

FDA Recall Z-1469-2022 · Posted None

Recalling FirmSIGHT DIAGNOSTICS LTD
Recall StatusOpen, Classified
Product CodeGKZ
Date Initiated2022-06-14
Product Quantity72 US; 292 OUS

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.

Firm Action

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.

Root Cause

Software Design Change

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K190898Sight OLOSight Diagnostics , Ltd. · 2019-11-01

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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