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

Hazard

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.

Details from the source

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. Quantity: 7,450 units (2,800 US, 4,650 OUS) Lot/code info: REF: TK1, UDI-DI: B787TK10, Lot Code: 10114

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.