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SIGHT DIAGNOSTICS LTD
1 federal recall on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for SIGHT DIAGNOSTICS LTD and translate it into plain English — free weekly digest, optional same-day alerts.
- 2024-07-03FDA-DeviceClass IISight OLO CBC Test Kit, Model/Catalog Number: TK1. A disposable cartridge and sample preparation tools for use with the Sight OLO CBC analyzer.
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.
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