The Sight OLO device is a computer vision based platform for blood… — Class II medical device recall Z-0963-2022
Ongoing recall by SIGHT DIAGNOSTICS LTD, reported 2022-04-27, distributed nationwide. In instances where custom reference ranges were configured on the device post installation, a possibility to i
| Recall number | Z-0963-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | SIGHT DIAGNOSTICS LTD, Tel Aviv-Yafo, Israel |
| Recall initiated | 2022-01-20 |
| Classified | 2022-04-21 |
| Reported by FDA | 2022-04-27 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AU, CA, CL, CW, DE, FI, GB, GR, HK, IE, IL, IT, MX, NL, PT, SG, SI |
| Reason classes | software |
| Serial numbers | Q100, Q113, Q121, Q138, Q140, Q142, Q145, Q146, Q157, Q159, Q162, Q166, Q167, Q170, Q175, Q176, Q177, Q179, Q180, Q189, Q191, Q204, Q205, Q206, Q208 and 297 more |
Product
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.
Reason for recall
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
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.