SIGHT DIAGNOSTICS LTD: FDA recalls
FDA enforcement reports name SIGHT DIAGNOSTICS LTD as the recalling firm in 4 events. The events have 4 product records. The recalls started from 2021 to 2024. All the events are device recalls.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Enforcement events
4 events, newest first.
| Initiated | Product (first record) | Type | Class | Records | Status |
|---|---|---|---|---|---|
| 13 May 2024 | Sight OLO CBC Test Kit, Model/Catalog Number: TK1. A disposable cartridge and sample preparation tools for use with the Sight OLO CBC analyzer. | Device | Class II | 1 | Ongoing |
| 14 Jun 2022 | Sight OLO, Automated Hematology Analyzer, Catalog No. OLO-U1 | Device | Class II | 1 | Ongoing |
| 20 Jan 2022 | 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… | Device | Class II | 1 | Ongoing |
| 17 Mar 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 1.10 | Device | Class II | 1 | Terminated |
An event with 1 product record and a class that is not Class I has no page. It has a row in this table.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Recalling firm: The firm that the FDA record names for a recall.
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Type and class
| Type | Events |
|---|---|
| Device | 4 |
| Class | Events |
|---|---|
| Class II | 4 |
- Share of the events of the firm in Class I
- 0%
- Share of all events on the register in Class I
- 18%
- Events with the status Ongoing
- 3
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Events by year
Official channels
- FDA enforcement reportsThe FDA search of the weekly enforcement reports.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA: report a problemThe FDA page that shows where a report about a product goes.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
Cite this page
Recall Register. SIGHT DIAGNOSTICS LTD: FDA recalls. https://recallregister.com/firm/sight-diagnostics-ltd/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
The firm name is the spelling in the FDA records. A company with 2 spellings has 2 pages.
A firm with more products can have more recalls. This site does not compare one firm with a different firm. How the register is made. Report an error.
Questions
- Which classes do the FDA recalls of SIGHT DIAGNOSTICS LTD have?
- Class II: 4 events. The class is for the product of a recall. It is not a class of the firm.
- What is the newest FDA recall of SIGHT DIAGNOSTICS LTD?
- FDA event 94678, which the firm started on 13 May 2024. The first product in the record is:
Sight OLO CBC Test Kit, Model/Catalog Number: TK1. A disposable cartridge and sample preparation tools for use with the Sight OLO CBC analyzer.
- How many FDA recalls of SIGHT DIAGNOSTICS LTD have the status Ongoing?
- 3 events have the status Ongoing in the openFDA file. openFDA says about the status:
FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.