# FDA recall Z-2517-2021

> **SIGHT DIAGNOSTICS LTD** · Class II · device recall initiated 2021-03-17.

## Product

Sight OLO-E1/U1 Software and Operators Manual  Software v2.56.1  Catalog #: 1 OLO-U1    Catalog #: 2 OLO-E1  revision 1.9, revision 1.10

## Reason for recall

Discrepancy in labeling between the adult CBC reference ranges presented in the OLO Operator's Manual and the OLO software

## Distribution

Worldwide distribution - US Nationwide distribution in the states of Alabama, Florida,  Massachusetts, Minnesota, Missouri, New York, Ohio, Texas, Virginia, Washington and the countries of AUSTRALIA, CHILE, UNITED KINGDOM, GEORGIA, ISRAEL, Mexico,  NETHERLANDS, Portugal, Russia, Singapore, Thailand.

## Key facts

- **Recall number:** Z-2517-2021
- **Recalling firm:** SIGHT DIAGNOSTICS LTD
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-03-17
- **Report date:** 2021-09-29
- **Termination date:** 2022-06-08

- **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-2517-2021

## Citation

> AI Analytics. FDA recall Z-2517-2021. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-2517-2021. Source: US FDA. Licensed CC0.

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