Recall Z-1469-2022— SIGHT DIAGNOSTICS LTD

Name: FDA recall Z-1469-2022
Creator: U.S. Food and Drug Administration
Published: 2022-06-14

Class II · Ongoing

Class II FDA medical device recall by SIGHT DIAGNOSTICS LTD, initiated 2022-06-14. It names one FDA 510(k) clearance: K190898. Product: Sight OLO, Automated Hematology Analyzer, Catalog No. OLO-U1. Reason: 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..

Recalling firm: SIGHT DIAGNOSTICS LTD
Classification: Class II
Status: Ongoing
Initiated: 2022-06-14
Firm location: Tel Aviv-Yafo, Israel

510(k) clearances named in this recall

1 on FDA's record

K190898 — Sight OLOSight Diagnostics , Ltd.·cleared 2019-11-01

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.