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-E1/U1 Software and Operators Manual Software v2.56.1 Catalog #: Recalled by SIGHT DIAGNOSTICS LTD Due to Discrepancy in labeling between the adult CBC reference...

Date: March 17, 2021
Company: SIGHT DIAGNOSTICS LTD
Status: Terminated
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-E1/U1 Software and Operators Manual Software v2.56.1 Catalog #: 1 OLO-U1 Catalog #: 2 OLO-E1 revision 1.9, revision 1.10

Quantity: 114 units

Why Was This Recalled?

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

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