Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
The Sight OLO device is a computer vision based platform Recalled by SIGHT DIAGNOSTICS LTD Due to In instances where custom reference ranges were configured...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact SIGHT DIAGNOSTICS LTD directly.
Affected Products
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.
Quantity: 322 units: U.S 109 Foreign 213
Why Was This Recalled?
In instances where custom reference ranges were configured on the device post installation, a possibility to inadvertently apply changes to reference range values was found on software versions 2.59.3 and all earlier versions, which can potentially lead to displaying and printing incorrectly-configured reference range values
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About SIGHT DIAGNOSTICS LTD
SIGHT DIAGNOSTICS LTD has 4 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report