Medical Device Recall: Sight OLO CBC Test Kit, Model/Catalog Number: TK1. A disposable cartridge and sample preparation tools for use with the Sight OLO CBC analyzer.
SIGHT DIAGNOSTICS LTD · May 13, 2024
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.
States Affected
NATIONWIDE
Quantity Affected
7,450 units (2,800 US, 4,650 OUS)
Source: FDA (openFDA Device Enforcement)
Recall number: Z-2173-2024
Status: ongoing
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