Drug recall
The Sight OLO device is a computer vision based platform for blood analysis. The platform combines…
FDA recall event 89645 · Class II · SIGHT DIAGNOSTICS LTD
Key facts
| Event ID | 89645 |
|---|---|
| Recall numbers | Z-0963-2022 |
| Recalling firm | SIGHT DIAGNOSTICS LTD |
| Product type | Devices |
| 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… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | Jan 20, 2022 |
| Report date | Apr 27, 2022 |
| City | Tel Aviv-Yafo |
| Country | Israel |
| FEI number | 3016099075 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: