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FDAMay 13, 2024device

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

Official recall recorded by the U.S. Food & Drug Administration.

The 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.

What to do

FDA enforcement status: Ongoing

Brands named

sight diagnosticssight

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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