Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Sight OLO Recalled by SIGHT DIAGNOSTICS LTD Due to The default reference ranges for MCH, MCHC, and...

Date: June 14, 2022
Company: SIGHT DIAGNOSTICS LTD
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact SIGHT DIAGNOSTICS LTD directly.

Affected Products

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

Quantity: 72 US; 292 OUS

Why Was This 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.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About SIGHT DIAGNOSTICS LTD

SIGHT DIAGNOSTICS LTD has 4 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report