FDA recall Z-2173-2024

SIGHT DIAGNOSTICS LTD · Class II · device

Product

Sight OLO CBC Test Kit, Model/Catalog Number: TK1. A disposable cartridge and sample preparation tools for use with the Sight OLO CBC analyzer.

Reason for recall

One Test Kit lot (TK1-10114) shows a positive bias in the platelet count due to bacterial contamination which can result in elevated counts with a bias of 7.5 k/ul. This results in the test kit lot performing outside of the device specification.

Distribution

Worldwide - US Nationwide distribution in the states of AL, FL, MS, TX, WI and the countries of Canada, Israel, Slovenia, Trinidad & Tobago.

Key facts

Status
Ongoing
Initiation date
2024-05-13
Report date
2024-07-03
Voluntary/Mandated
Voluntary: Firm initiated
Location
Tel Aviv-Yafo, Israel

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2173-2024