Sight OLO Blood Analysis Device: Incorrect Reference Ranges May Display
The Sight OLO blood analysis device may display and print incorrect reference ranges in software versions 2.59.3 and earlier. This could occur when custom reference ranges were configured after device installation.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 risk-of-harm device issue where the software error could result in incorrect laboratory test result values being displayed and reported, potentially leading to diagnostic errors. No illnesses or injuries have been reported, and the hazard remains theoretical. The device is operating under FDA Class II classification.
Plain-English summary
The Sight OLO is a computer-vision-based medical device used for blood analysis. It identifies and quantifies blood components through image processing algorithms and provides complete blood count (CBC) analysis with 5-part white blood cell differentials.
A software vulnerability has been identified in Sight OLO devices running software version 2.59.3 and all earlier versions. When custom reference ranges are manually configured on the device after installation, the software may inadvertently apply changes that result in incorrectly-configured reference range values being displayed and printed with test results.
The recall affects 322 units worldwide: 109 in the United States and 213 distributed internationally. Affected countries include Australia, Canada, Chile, Curaçao, Finland, Georgia, Germany, Greece, Hong Kong, Ireland, Israel, Italy, Mexico, Netherlands, Portugal, Singapore, Slovenia, United Arab Emirates, and the United Kingdom.
Laboratories and healthcare facilities should contact Sight Diagnostics Ltd for guidance on addressing this issue.
The recalled product
- Product
- The Sight OLO device is a computer vision based platform for blood analysis. The platform combines computer-vision algorithms for image processing to identify and quantify blood components (e.g., red blood cells) and their characteristics (e.g., cell volume) in an automated…
- Manufacturer
- SIGHT DIAGNOSTICS LTD
Distribution
Distributed nationwide across the United States.
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