Lower risk Medical device recall · FDA · Published January 20, 2022

Sight OLO Blood Analyzer Software Versions 2.59.3 and Earlier May Display Incorrect

Sight Diagnostics recalls The Sight OLO blood analysis device with software versions 2.59.3 and earlier may display incorrect reference range values after custom configuration. Affected units have specific serial numbers listed in the recall notice.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0963-2022Medical device Sight Diagnostics ›

Lower-risk recall

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

Take action

Contact the company

Recalling firmSIGHT DIAGNOSTICS LTD23, Derekh Menakhem Begin · Tel Aviv-Yafo, Israel

✎ GovInfoNow plain-language explainer

Sight Diagnostics is recalling The Sight OLO blood analysis device software versions 2.59.3 and all earlier versions. These versions may display and print incorrectly configured reference range values after custom reference ranges are set up. This could lead to inaccurate blood test results. Read more at govinfonow.com/recall/61238-sight-olo-blood-analyzer-software-versions-2-59-3-and.

Source Summary by GovInfoNow · govinfonow.com/recall/61238-sight-olo-blood-analyzer-software-versions-2-59-3-and · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0963-2022

Cite this page

“Sight OLO Blood Analyzer Software Versions 2.59.3 and Earlier May Display Incorrect.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61238-sight-olo-blood-analyzer-software-versions-2-59-3-and. Based on FDA recall #Z-0963-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0963-2022%22&limit=1).

The Food and Drug Administration announced on Jan. 20, 2022, that Sight Diagnostics is recalling The Sight OLO device due to a software error that can display incorrectly-configured reference range values. Owners should contact the company for a remedy. GovInfoNow's records show this Class II recall involves 322 units distributed worldwide.

How to tell if you have it

Brand: Sight Diagnostics
Product: The Sight OLO device
Software versions: 2.59.3 and all earlier versions
Serial Number UDI (US): Q100 +B787OLOU10/$$+7Q-100G through Q687 +B787OLOE10/$$+7Q-687-
Serial Number UDI (OUS): Q113 +B787OLOE10/$$+7Q-1134 through Q94 +B787OLOE10/$$+7Q-094C
Units affected: 322

The hazard

The recall addresses a possibility to inadvertently apply changes to reference range values when custom ranges were configured post-installation. This software issue can lead to displaying and printing incorrectly-configured reference range values.

Context

GovInfoNow's records show Sight Diagnostics has issued three other recalls since March 17, 2021. On May 13, 2024, the company recalled a Sight OLO CBC Test Kit due to bacterial contamination causing false high platelet counts. A June 14, 2022 recall addressed incorrect reference ranges for children on software versions 2.63 and later. The earliest recorded recall, dated March 17, 2021, involved labeling discrepancies in CBC reference ranges for software v2.56.1.

How to tell if you have this one

Check if your The Sight OLO device has software version 2.59.3 or earlier. Affected units have specific serial numbers listed in the recall notice, including UDI codes starting with Q100, Q121, Q138, and many others.

Brand
Sight Diagnostics
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Software Version
Verify your The Sight OLO device's software version by checking the device settings or documentation. If it is 2.59.3 or earlier, it is affected.
Update Software
Update to a newer software version that is not affected by this issue to ensure correct reference range values are displayed and printed.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA 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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA published this recall 3 months after the firm started it.

Jan 20, 2022Firm started the recall
Apr 21, 2022FDA classified it Class II
Apr 27, 2022Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/61238-sight-olo-blood-analyzer-software-versions-2-59-3-and">Sight OLO Blood Analyzer Software Versions 2.59.3 and Earlier May Display Incorrect (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0963-2022 (January 20, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0963-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.