# FDA recall Z-0963-2022

> **SIGHT DIAGNOSTICS LTD** · Class II · device recall initiated 2022-01-20.

## Product

The Sight OLO device is a computer vision based platform for blood analysis. The platform  combines computer-vision algorithms for image processing to identify and quantify blood  components (e.g., red blood cells) and their characteristics (e.g., cell volume) in an  automated fashion. Using dedicated staining, the proposed platform provides complete  blood count analysis. The Sight OLO is a compact device, designed to be automated and  simple to operate, to enable rapid testing and analysis. The Sight OLO consists of a  scanning and analyzing device and a CBC test kit, including disposable cartridges and  sample preparation tools. The disposable cartridge containing the blood sample is loaded  into the device through the loading slot. The device is operated through the touch screen  interface. The Sight OLO provides complete blood count information with 5-part differentials for white blood cell types. Specifically, the CBC parameters measured by the Sight OLO are listed below and incl

## Reason for recall

In instances where custom reference ranges were configured on the device post installation,  a possibility to inadvertently apply changes to reference range values was found on software  versions 2.59.3 and all earlier versions, which can potentially lead to displaying and printing  incorrectly-configured reference range values

## Distribution

Worldwide distribution - US Nationwide and the countries of AUSTRALIA, CANADA, CHILE, CURACAO, FINLAND, GEORGIA, GERMANY, GREECE, HONG KONG, IRELAND, ISRAEL, ITALY,  MEXICO, NETHERLANDS, PORTUGAL, SINGAPORE, SLOVENIA, UNITED ARAB EMIRATES,  UNITED KINGDOM.

## Key facts

- **Recall number:** Z-0963-2022
- **Recalling firm:** SIGHT DIAGNOSTICS LTD
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-01-20
- **Report date:** 2022-04-27

- **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-0963-2022

## Citation

> AI Analytics. FDA recall Z-0963-2022. Retrieved 2026-07-27 from https://api.ai-analytics.org/recall/Z-0963-2022. Source: US FDA. Licensed CC0.

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