Sight Diagnostics Ltd
Medical device manufacturer in Tel Aviv-Yafo, Isra.
1510(k) clearances
0PMA approvals
4recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K190898 | Sight OLOGKZ · Traditional | 11/01/2019SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-2173-2024 Class II | Sight OLO CBC Test Kit, Model/Catalog Number: TK1. A disposable cartridge and sample…One Test Kit lot (TK1-10114) shows a positive bias in the platelet count due to bacterial contamination… | 05/13/2024Open, Classified |
| Z-1469-2022 Class II | Sight OLO, Automated Hematology Analyzer, Catalog No. OLO-U1The default reference ranges for MCH, MCHC, and RDW for age group "Child 2-11y" are mixed up and incorrectly… | 06/14/2022Open, Classified |
| Z-0963-2022 Class II | The Sight OLO device is a computer vision based platform for blood analysis. The…In instances where custom reference ranges were configured on the device post installation, a possibility to… | 01/20/2022Open, Classified |
| Z-2517-2021 Class II | Sight OLO-E1/U1 Software and Operators Manual Software v2.56.1 Catalog #: 1 OLO-U1…Discrepancy in labeling between the adult CBC reference ranges presented in the OLO Operator's Manual and… | 03/17/2021Terminated |