The Recall Desk
HighFDA (Devices)·Z-2517-2021·Announced 2021-09-29

Sight OLO-E1/U1 Reference Range Labeling Discrepancy in Software

The Sight OLO-E1/U1 diagnostic device software contains a labeling discrepancy: the operator's manual and software present different adult CBC reference ranges, potentially affecting the interpretation of diagnostic results.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a Class II medical device with a labeling discrepancy directly affecting clinical reference information. The mismatch between manual and software reference ranges creates a documented risk of diagnostic interpretation error. No reported illnesses or injuries are documented in the source material, which prevents a higher severity score.

Plain-English summary

The Sight OLO-E1/U1 is a diagnostic device manufactured by Sight Diagnostics Ltd. The recall addresses a discrepancy in labeling where the adult complete blood count (CBC) reference ranges presented in the operator's manual do not match those in the OLO software (v2.56.1).

This discrepancy creates ambiguity for device operators. Depending on which source they consult—the manual or the software—they may use different reference ranges when interpreting diagnostic results, potentially leading to inconsistent clinical interpretation.

The affected software and documentation includes Catalog #1 OLO-U1 and Catalog #2 OLO-E1 (revisions 1.9 and 1.10). Approximately 114 units have been distributed worldwide, including throughout the United States in Alabama, Florida, Massachusetts, Minnesota, Missouri, New York, Ohio, Texas, Virginia, and Washington, as well as internationally to Australia, Chile, United Kingdom, Georgia, Israel, Mexico, Netherlands, Portugal, Russia, Singapore, and Thailand.

Users of affected devices should identify and verify which reference ranges are correct and ensure consistency in their clinical workflows. Contact the manufacturer or the FDA for clarification on the authoritative reference values.

The recalled product

Product
Sight OLO-E1/U1 Software and Operators Manual Software v2.56.1 Catalog #: 1 OLO-U1 Catalog #: 2 OLO-E1 revision 1.9, revision 1.10
Manufacturer
SIGHT DIAGNOSTICS LTD
Category
Medical Device — Diagnostic Equipment
Hazard
  • labeling-discrepancy
  • reference-range-mismatch

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Software v2.56.1 Catalog #: 1 OLO-U1 Catalog #: 2 OLO-E1 revision 1.9
  • revision 1.10

Distribution

Distributed nationwide across the United States.

Related recalls

Same category