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.
Sight OLO automated hematology analyzers with specific software versions have mixed-up reference ranges for children aged 2-11 years. This can cause test results to appear within or outside the correct reference ranges, potentially leading to misdiagnosis.
The software displays mixed-up reference ranges for children 2-11 years, causing test results to incorrectly show as within or outside the intended reference ranges. This could lead to misdiagnosis if healthcare providers rely on these results without noticing the error.
Users of Sight OLO hematology analyzers with software versions 2.63, 2.63.1, and 2.63.1.1 that are used for children aged 2-11 years. Laboratory staff and healthcare providers who run these devices are most at risk of incorrect test results.
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.
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.
If you have run tests on children aged 2-11 years, review results to ensure they align with expected reference ranges.
Software versions 2.63, 2.63.1, and 2.63.1.1.
Check if your device has a serial number listed in the recall (Q245 to Q959) and software version 2.63, 2.63.1, or 2.63.1.1.
No action is required if your device has a different software version or serial number not listed in the recall.
We’ve drafted a message you can send Sight OLO to request your refund or repair — edit it as you like.
Subject: Recall Z-1469-2022 — Sight OLO Sight OLO Hello, I own a Sight OLO that is covered by recall Z-1469-2022 from Sight OLO. 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.
