Hematology Analyzer Sight OLO Displays Incorrect Pediatric Reference Ranges
The Sight OLO automated hematology analyzer displays mixed-up default reference ranges for children ages 2-11 in software versions 2.63, 2.63.1, and 2.63.1.1, which could cause test results to appear incorrectly normal or abnormal.
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 an FDA Class II medical device recall involving a software error that displays incorrect reference ranges in a diagnostic device. The hazard presents a risk of patient misdiagnosis, but no illnesses, injuries, or hospitalizations have been reported. Per the severity rubric, risk-of-harm products where injury has not yet been reported are classified as High.
Plain-English summary
The Sight OLO is an automated hematology analyzer used in clinical settings to perform blood cell counts and analysis. Devices running software versions 2.63, 2.63.1, or 2.63.1.1 display incorrect default reference ranges for three blood measurements (MCH, MCHC, and RDW) when analyzing blood samples from children ages 2-11 years.
Due to this display error, test results on affected devices may incorrectly appear to be within or outside the normal reference range. This could result in misinterpretation of blood test results.
Approximately 72 units were distributed in the United States across 21 states, and 292 units were distributed internationally to countries including Canada, the United Kingdom, Germany, Spain, and others. Affected devices can be identified by the UDI-DI B787OLOU10 and the specified serial numbers and software versions in the FDA notice.
The recalled product
- Product
- Sight OLO, Automated Hematology Analyzer, Catalog No. OLO-U1
- Manufacturer
- SIGHT DIAGNOSTICS LTD
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)
- UDI-DI: B787OLOU10 Software versions 2.63
- 2.63.1
Distribution
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