Recall Z-0963-2022 ยท GKZ Counter, Differential Cell
SIGHT DIAGNOSTICS LTD
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 d
| Date | Jan 20, 2022 |
| Status | Open, Classified |
| Reason | 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 |
| Root cause | Software design |
| Action | 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. Pl |
| Quantity | 322 units: U.S 109 Foreign 213 |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K190898 | Sight OLO Sight Diagnostics , Ltd., Nov 1, 2019 |