# FDA recall Z-1469-2022

> **SIGHT DIAGNOSTICS LTD** · Class II · device recall initiated 2022-06-14.

## Product

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.

## 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.

## Key facts

- **Recall number:** Z-1469-2022
- **Recalling firm:** SIGHT DIAGNOSTICS LTD
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-06-14
- **Report date:** 2022-08-03

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Tel Aviv-Yafo, Israel

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1469-2022

## Citation

> AI Analytics. FDA recall Z-1469-2022. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1469-2022. Source: US FDA. Licensed CC0.

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