Diagnostics makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in IsraelLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 3 spellings of its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list Sight Diagnostics Ltd. with 4 device recalls, 1 510(k) clearance and 1 AI-enabled device. The most recent is a device recall dated May 13, 2024: Sight OLO CBC Test Kit, Model/Catalog Number: TK1. A disposable cartridge and sample pre….
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| May 13, 2024 | Sight OLO CBC Test Kit, Model/Catalog Number: TK1. A disposable cartridge and sample preparation tools for use with the Sight OLO CBC analyzClass II · One Test Kit lot (TK1-10114) shows a positive bias in the platelet count due to bacterial contamination which can result | Device recalls |
| Jun 14, 2022 | Sight OLO, Automated Hematology Analyzer, Catalog No. OLO-U1Class II · The default reference ranges for MCH, MCHC, and RDW for age group "Child 2-11y" are mixed up and incorrectly displayed o | Device recalls |
| Jan 20, 2022 | The Sight OLO device is a computer vision based platform for blood analysis. The platform combines computer-vision algorithms for image proClass II · In instances where custom reference ranges were configured on the device post installation, a possibility to inadverten | Device recalls |
| Mar 17, 2021 | Sight OLO-E1/U1 Software and Operators Manual Software v2.56.1 Catalog #: 1 OLO-U1 Catalog #: 2 OLO-E1 revision 1.9, revision 1.10Class II · Discrepancy in labeling between the adult CBC reference ranges presented in the OLO Operator's Manual and the OLO softwa | Device recalls |
| Nov 1, 2019 | Sight OLOK190898 · GKZ | 510(k) clearances |
| Nov 1, 2019 | Sight OLOK190898 · Hematology | AI-enabled devices |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
