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
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.
The software displays adult CBC reference ranges that differ from those in the operator's manual. This discrepancy could lead to incorrect blood test results if users follow the software's ranges instead of the manual's.
Users of the OLO-E1/U1 blood analysis devices with software version 2.56.1 and revision 1.9 or 1.10 are affected. Laboratory staff and healthcare professionals who use these devices are most at risk of incorrect blood test results.
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.
Verify the software version and device revision on your OLO-E1/U1 device.
The recall is due to discrepancies between the adult CBC reference ranges in the software and those in the operator's manual, which could lead to incorrect blood test results.
Check your software version and device revision. If you have version 2.56.1 with revision 1.9 or 1.10, you may need to update to a newer version.
The official recall does not specify a fix; users should check for updated software versions.
We’ve drafted a message you can send Sight Diagnostics to request your refund or repair — edit it as you like.
Subject: Recall Z-2517-2021 — Sight Diagnostics Sight Diagnostics Hello, I own a Sight Diagnostics that is covered by recall Z-2517-2021 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.
