Reported Aug 3, 2022 · Ongoing
Sight OLO, Automated Hematology Analyzer, Catalog No. OLO-U1
Sight Diagnostics Ltd.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: SIGHT DIAGNOSTICS LTD · 23, Derekh Menakhem Begin · Tel Aviv-Yafo · N/A
Is this the product you have?
- Sight OLO, Automated Hematology Analyzer, Catalog No. OLO-U1
- Lot codes and dates
- UDI-DI
B787OLOU10 Software versions 2.632.63.1and 2.63.1.1
- Serial Number
371 of 371 codes
Q245Q516Q560Q648Q684Q688Q792Q794Q840Q600Q632Q883Q890Q209Q789Q489Q496Q287Q221Q256Q523Q575Q783Q801Q802Q812Q813Q817Q831Q835Q850Q870Q871Q892Q775Q873Q322Q836Q846Q308Q354Q263Q650Q535Q473Q691Q698Q768Q448Q428Q545Q780Q379Q404Q412Q377Q284Q234Q549Q744
- UDI-DI
- Amount recalled
- 72 US; 292 OUS
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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