Lower riskMedical device recall · FDA · Published June 14, 2022
Sight OLO Hematology Analyzer Software Error: Incorrect Reference Ranges for Children
Sight OLO automated hematology analyzers with software versions 2.63, 2.63.1, and 2.63.1.1 may display mixed-up reference ranges for children 2-11 years, causing inaccurate test results. Affected units should be checked for serial numbers listed.
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.
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Contact the company
📍Recalling firmSIGHT DIAGNOSTICS LTD23, Derekh Menakhem Begin · Tel Aviv-Yafo, Israel
“Sight OLO Hematology Analyzer Software Error: Incorrect Reference Ranges for Children.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/60509-sight-olo-hematology-analyzer-software-error-incorrect-reference-ranges-for. Based on FDA recall #Z-1469-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1469-2022%22&limit=1).
The Food and Drug Administration announced on June 14, 2022, that Sight Diagnostics Ltd. is recalling its Sight OLO Automated Hematology Analyzer due to incorrect reference range displays for children aged 2-11 years. The agency said the error may cause results to appear within or outside the correct reference range.
How to tell if you have it
Brand: Sight OLO
Product: Automated Hematology Analyzer
Catalog No.: OLO-U1
Software versions: 2.63, 2.63.1, and 2.63.1.1
The hazard
According to the FDA, the default reference ranges for MCH, MCHC, and RDW for the age group "Child 2-11y" are mixed up and incorrectly displayed on affected devices. Due to this issue, results may incorrectly appear to be within or outside the reference range.
Context
GovInfoNow's records show Sight Diagnostics Ltd. has issued three other recalls since March 17, 2021. Other recent recalls of similar products include a May 13, 2024 recall for bacterial contamination in CBC Test Kits and a Jan. 20, 2022 recall regarding incorrect reference ranges in software versions 2.59.3 and earlier.
How to tell if you have this one
Check if your Sight OLO hematology analyzer has software versions 2.63, 2.63.1, or 2.63.1.1. The serial numbers listed in the recall record (Q245 to Q959) indicate affected units.
Brand
Sight OLO
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Software Version
Verify your device's software version by checking the device settings or documentation. If it is 2.63, 2.63.1, or 2.63.1.1, it is affected.
Review Test Results
If you have run tests on children aged 2-11 years, review results to ensure they align with expected reference ranges.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 21 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Worldwide distribution - US Nationwide distribution in the states of Alabama, Arizona, California, Florida, Idaho, Illinois, Kansas, Kentucky, Massachusetts, Michigan, Minnesota, Mississippi, New Jersey, Ohio, Pennsylvania, South Carolina,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Arizona, California, Florida, Idaho, Illinois, Kansas, Kentucky, Massachusetts, Michigan, Minnesota, Mississippi, New Jersey, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin.
Recall timeline
FDA published this recall 50 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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-1469-2022 (June 14, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1469-2022 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.