The Sight OLO device is a computer vision based platform for blood analysis. The platform
combines computer-vision algorithms for image processing to identify and quantify blood
components (e.g., red blood cells) and their characteristics (e.g., cell volume) in an
automated fashion. Using dedicated staining, the proposed platform provides complete
blood count analysis. The Sight OLO is a compact device, designed to be automated and
simple to operate, to enable rapid testing and analysis. The Sight OLO consists of a
scanning and analyzing device and a CBC test kit, including disposable cartridges and
sample preparation tools. The disposable cartridge containing the blood sample is loaded
into the device through the loading slot. The device is operated through the touch screen
interface. The Sight OLO provides complete blood count information with 5-part differentials for white blood cell types. Specifically, the CBC parameters measured by the Sight OLO are listed below and include: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW, PLT, NEUT%/#,
LYMPH %/#, MONO %/#, EO%/# and BASO%/#. In addition, the Sight OLO signals specific
WBC abnormal cases by flagging the sample.
Recall Date: Jan 20, 2022
Mfg:
SIGHT DIAGNOSTICS LTD
Recall ID: 89645
Product ID: 192103
Enforcement Date: Apr 27, 2022
Last Published: Apr 21, 2022
__________
Emert Number: Z-0963-2022
Emert Status: Notified