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
- Recall Number
- Z-0963-2022
- Event Number
- 89645
- Firm
- SIGHT DIAGNOSTICS LTD 23, Derekh Menakhem Begin Tel Aviv-Yafo Israel
- FEI Number
- 3016099075
- Product Code
- GKZ
- Status
- Open, Classified
- Root Cause
- Software design
- Initiated
- January 20, 2022
Description
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.
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
Sight Diagnostics issued Medical Device Recall Notification on 1/20/22 via email to Distributors and End Users. Letter states reason for recall, health risk and action to take: In case you have configured your own reference ranges, please review the configured values to ensure all values are set properly. You can then continue to use your OLO analyzer. The software version of the OLO analyzer in your possession will be updated to a new version that resolves this software defect. The update will be performed remotely by Sights product specialists, who will contact you to schedule the update. Please be aware that the software version update requires the analyzer to be connected to the internet. If you need to make any adjustments to your reference ranges before the software update is performed, please avoid pressing the Cancel button while editing a reference range parameter, and always review all parameters after making any changes, to confirm values are set properly. If you are a distributor, please share this recall notification letter with any customer to whom the product was shipped, or may have been shipped. You are kindly requested to fill the attached Acknowledgement and Receipt Form, and return it to [email protected] within 30 days. Software version 2.63 was released and includes the fix for the software defect mentioned above. Questions please contact us at [email protected]. For full indications for use and safety information please refer to the Quality and Compliance page at www.sightdx.com.
Worldwide distribution - US Nationwide and the countries of AUSTRALIA, CANADA, CHILE, CURACAO, FINLAND, GEORGIA, GERMANY, GREECE, HONG KONG, IRELAND, ISRAEL, ITALY, MEXICO, NETHERLANDS, PORTUGAL, SINGAPORE, SLOVENIA, UNITED ARAB EMIRATES, UNITED KINGDOM.
322 units: U.S 109 Foreign 213