--- title: "SIGHT DIAGNOSTICS LTD Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search SIGHT DIAGNOSTICS LTD recall records, lots, firms and dates. Reported status can be incomplete; use the linked agency notice for current instructions." url: https://isitonrecall.com/brand/sight-diagnostics-ltd/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # SIGHT DIAGNOSTICS LTD recall records **3** reported ongoing 3 records in this archive. Latest source date May 13, 2024. FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## Records and reported status May 13, 2024 FDA device enforcement ### [Sight OLO CBC Test Kit, Model/Catalog Number: TK1. A disposable cartridge and sample preparation tools for use with the Sight OLO CBC analyzer.](https://isitonrecall.com/recall/fda-device-z-2173-2024-sight-olo-cbc-test-kit-model-catalog-number-tk1-a-disposable-cartridge-and-sample-preparation-tools/) One Test Kit lot (TK1-10114) shows a positive bias in the platelet count due to bacterial contamination which can result in elevated counts with a bias of 7.5 k/ul. This results in the test kit lot performing outside of the device specification. Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution in the states of AL, FL, MS, TX, WI and the countries of Canada, Israel, Slovenia, Trinidad & Tobago. [Official source for Sight OLO CBC Test Kit, Model/Catalog Number: TK1. A disposable cartridge and sample preparation ...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2173-2024%22) Jun 14, 2022 FDA device enforcement ### [Sight OLO, Automated Hematology Analyzer, Catalog No. OLO-U1](https://isitonrecall.com/recall/fda-device-z-1469-2022-sight-olo-automated-hematology-analyzer-catalog-no-olo-u1/) The default reference ranges for MCH, MCHC, and RDW for age group "Child 2-11y" are mixed up and incorrectly displayed on OLO devices running software version 2.63, 2.63.1, and 2.63.1.1. Due to the issue, results may incorrectly appear to be within or outsi... Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide distribution in the states of Alabama, Arizona, California, Florida, Idaho, Illinois, Kansas, Kentucky, Massachusetts, Michigan, Minnesota... [Official source for Sight OLO, Automated Hematology Analyzer, Catalog No. OLO-U1](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1469-2022%22) Jan 20, 2022 FDA device enforcement ### [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...](https://isitonrecall.com/recall/fda-device-z-0963-2022-the-sight-olo-device-is-a-computer-vision-based-platform-for-blood-analysis-the-platform-combines-co/) 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 ... Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide and the countries of AUSTRALIA, CANADA, CHILE, CURACAO, FINLAND, GEORGIA, GERMANY, GREECE, HONG KONG, IRELAND, ISRAEL, ITALY, MEXICO, NETH... [Official source for The Sight OLO device is a computer vision based platform for blood analysis. The platform combine...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0963-2022%22) ## Reasons in these listed records - One Test Kit lot (TK1-10114) shows a positive bias in the platelet count due to bacterial contamination which can result in elevated counts with a bias of 7.5 k/ul. This results in the test kit lot performing outside of the device specification. - The default reference ranges for MCH, MCHC, and RDW for age group "Child 2-11y" are mixed up and incorrectly displayed on OLO devices running software version 2.63, 2.63.1, and 2.63.1.1. Due to the issue, results may incorrectly appear to be within or outside the reference range. - 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 print... These examples come from this result page and are not a ranking of every recall reason. ## Checking SIGHT DIAGNOSTICS LTD ### Is there a recall on sight diagnostics ltd right now? This archive contains 3 records, including 3 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product. ### How do I check my package or product? Compare the product, firm and lot, date, model or serial identifiers with the notice. [Use the label-check guide](https://isitonrecall.com/guides/read-lot-codes/) if you need help locating an identifier. ### Does a matching name mean every item is included? A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall. ### What if the search finds no matching record? This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. [Check source coverage](https://isitonrecall.com/sources/) and the agency's current notices. ### Where can I find older records? Use [monthly archives](https://isitonrecall.com/archives/) or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page. ## Keep checking [Search SIGHT DIAGNOSTICS LTD](https://isitonrecall.com/check/?q=SIGHT%20DIAGNOSTICS%20LTD) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)