Lower riskMedical device recall · FDA · Published March 17, 2021
Sight OLO-E1/U1 Software v2.56.1: Labeling Discrepancy in CBC Reference Ranges
Sight Diagnostics recalls OLO-E1/U1 software v2.56.1 due to labeling discrepancies between the software and operator manual's adult CBC reference ranges. This may lead to incorrect blood test results.
Discrepancy in labeling between the adult CBC reference ranges presented in the OLO Operator's Manual and the OLO software
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📍Recalling firmSIGHT DIAGNOSTICS LTD23, Derekh Menakhem Begin · Tel Aviv-Yafo, Israel
✎ GovInfoNow plain-language explainer
Sight Diagnostics is recalling software version 2.56.1 for OLO-E1/U1 devices because the reference ranges in the software don't match those in the operator's manual. This could cause incorrect blood test results if users rely on the software without checking the manual. Read more at govinfonow.com/recall/63048-sight-olo-e1-u1-software-v2-56-1-labeling-discrepancy.
“Sight OLO-E1/U1 Software v2.56.1: Labeling Discrepancy in CBC Reference Ranges.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63048-sight-olo-e1-u1-software-v2-56-1-labeling-discrepancy. Based on FDA recall #Z-2517-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2517-2021%22&limit=1).
Sight Diagnostics recalled Sight OLO-E1/U1 Software and Operators Manual Software v2.56.1 due to labeling discrepancies, the FDA announced on March 17, 2021. The recall affects 114 units distributed worldwide.
How to tell if you have it
Brand: Sight Diagnostics
Product: Sight OLO-E1/U1 Software and Operators Manual Software v2.56.1
Catalog #: 1 OLO-U1
Catalog #: 2 OLO-E1 revision 1.9
Catalog #: 2 OLO-E1 revision 1.10
The hazard
The hazard involves a discrepancy in labeling between the adult CBC reference ranges presented in the OLO Operator's Manual and the OLO software.
Context
GovInfoNow's records show Sight Diagnostics has had three other recalls since January 20, 2022. On May 13, 2024, a recall addressed bacterial contamination causing false high platelet counts in the Sight OLO CBC Test Kit. A June 14, 2022 recall corrected incorrect reference ranges for children in the Sight OLO Hematology Analyzer Software Error. An earlier January 20, 2022 notice warned that software versions 2.59.3 and earlier may display incorrect reference ranges.
How to tell if you have this one
Check for software version 2.56.1 and revision 1.9 or 1.10 on OLO-U1 and OLO-E1 devices. The recall covers specific software versions and device revisions.
Brand
Sight Diagnostics
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Software Version
Verify the software version and device revision on your OLO-E1/U1 device.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 10 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Worldwide distribution - US Nationwide distribution in the states of Alabama, Florida, Massachusetts, Minnesota, Missouri, New York, Ohio, Texas, Virginia, Washington and the countries of AUSTRALIA, CHILE, UNITED KINGDOM, GEORGIA, ISRAEL,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Florida, Massachusetts, Minnesota, Missouri, New York, Ohio, Texas, Virginia, Washington.
Recall timeline
FDA terminated this recall 15 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
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-2517-2021 (March 17, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2517-2021 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.