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.
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
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.
The software versions 2.59.3 and earlier may allow users to inadvertently apply changes to reference range values after custom reference ranges are configured. This can cause the device to display and print incorrectly configured reference ranges, potentially leading to inaccurate blood test results.
Users of The Sight OLO blood analysis device with software versions 2.59.3 and earlier are affected. Most at risk are healthcare professionals and individuals using the device for blood testing who have configured custom reference ranges.
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.
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 to a newer software version that is not affected by this issue to ensure correct reference range values are displayed and printed.
Software versions 2.59.3 and all earlier versions are affected.
Check your device's serial number against the list of affected units provided in the recall notice, which includes specific UDI codes starting with Q100, Q121, Q138, and many others.
Update your software to a newer version that is not affected by this issue to ensure correct reference range values are displayed and printed.
We’ve drafted a message you can send Sight Diagnostics to request your refund or repair — edit it as you like.
Subject: Recall Z-0963-2022 — Sight Diagnostics Sight Diagnostics Hello, I own a Sight Diagnostics that is covered by recall Z-0963-2022 from Sight Diagnostics. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
