Sight OLO, Automated Hematology Analyzer
Medical device recall Z-1469-2022. Published in FDA’s Enforcement Report on Aug 3, 2022.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Aug 3, 2022. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word, and 21 states named
- 72 US; 292 OUS how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“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.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Sight OLO, Automated Hematology Analyzer, Catalog No. OLO-U1
72 US; 292 OUS, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
UDI-DI: B787OLOU10 Software versions 2.63, 2.63.1, and 2.63.1.1 Serial Number: Q245 Q516 Q560 Q648 Q684 Q688 Q792 Q794 Q840 Q600 Q632 Q883 Q890 Q209 Q789 Q489 Q496 Q287 Q221 Q256 Q523 Q575 Q783 Q801 Q802 Q812 Q813 Q817 Q831 Q835 Q850 Q870…
Every code shown here, 1,933 characters
UDI-DI: B787OLOU10 Software versions 2.63, 2.63.1, and 2.63.1.1 Serial Number: Q245 Q516 Q560 Q648 Q684 Q688 Q792 Q794 Q840 Q600 Q632 Q883 Q890 Q209 Q789 Q489 Q496 Q287 Q221 Q256 Q523 Q575 Q783 Q801 Q802 Q812 Q813 Q817 Q831 Q835 Q850 Q870 Q871 Q892 Q775 Q873 Q322 Q836 Q846 Q308 Q354 Q263 Q650 Q535 Q473 Q691 Q698 Q768 Q448 Q428 Q545 Q780 Q379 Q404 Q412 Q377 Q284 Q234 Q549 Q744 Q755 Q762 Q617 Q218 Q385 Q848 Q852 Q877 Q677 Q872 Q880 Q770 Q236 Q924 Q413 Q415 Q313 Q324 Q175 Q572 Q484 Q709 Q568 Q776 Q285 Q243 Q246 Q262 Q267 Q282 Q289 Q296 Q298 Q159 Q191 Q216 Q261 Q272 Q293 Q305 Q326 Q339 Q376 Q382 Q386 Q395 Q406 Q410 Q421 Q435 Q441 Q445 Q455 Q457 Q458 Q461 Q466 Q475 Q480 Q481 Q483 Q490 Q493 Q504 Q508 Q514 Q528 Q529 Q530 Q531 Q533 Q539 Q540 Q544 Q546 Q554 Q558 Q563 Q566 Q567 Q576 Q578 Q582 Q584 Q588 Q591 Q610 Q612 Q615 Q618 Q621 Q631 Q635 Q637 Q642 Q643 Q645 Q646 Q649 Q651 Q652 Q653 Q654 Q655 Q656 Q660 Q662 Q665 Q666 Q672 Q675 Q683 Q685 Q689 Q690 Q693 Q694 Q696 Q699 Q703 Q707 Q710 Q711 Q714 Q718 Q719 Q721 Q723 Q724 Q725 Q727 Q728 Q733 Q735 Q736 Q737 Q738 Q739 Q740 Q742 Q745 Q747 Q748 Q749 Q752 Q753 Q760 Q764 Q766 Q767 Q769 Q771 Q777 Q784 Q785 Q787 Q790 Q793 Q795 Q797 Q799 Q803 Q804 Q806 Q810 Q815 Q402 Q407 Q454 Q670 Q702 Q713 Q715 Q717 Q720 Q726 Q741 Q743 Q754 Q772 Q773 Q774 Q781 Q782 Q786 Q796 Q849 Q888 Q897 Q900 Q904 Q905 Q907 Q908 Q912 Q917 Q926 Q929 Q930 Q931 Q932 Q933 Q934 Q938 Q940 Q941 Q943 Q944 Q945 Q949 Q950 Q951 Q952 Q954 Q955 Q958 Q176 Q625 Q443 Q623 Q805 Q494 Q894 Q127 Q394 Q679 Q708 Q746 Q759 Q100 Q167 Q264 Q273 Q403 Q418 Q470 Q570 Q577 Q581 Q765 Q417 Q704 Q667 Q664 Q527 Q452 Q138 Q757 Q761 Q808 Q820 Q823 Q824 Q825 Q826 Q829 Q462 Q400 Q387 Q303 Q659 Q830 Q620 Q859 Q398 Q463 Q673 Q918 Q638 Q552 Q732 Q145 Q436 Q807 Q543 Q882 Q534 Q634 Q821 Q541 Q833 Q837 Q319 Q886 Q898 Q614 Q451 Q705 Q669 Q384 Q365 Q798 Q270 Q121 Q788 Q816 Q465 Q467 Q499 Q551 Q565 Q352 Q283 Q661 Q515 Q668 Q212 Q520 Q633 Q391 Q791
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Worldwide distribution - US Nationwide distribution in the states of Alabama, Arizona, California, Florida, Idaho, Illinois, Kansas, Kentucky, Massachusetts, Michigan, Minnesota, Mississippi, New Jersey, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin and the countries of Burkina Faso, Belize, Canada, Cote D’Ivoire, Cameroon, Curacao, Germany, Spain, Finland, United Kingdom, Greece, Hong Kong, Indonesia, Ireland, Israel, India, Italy, Mexico, Portugal, Qatar, Sweden, Slovenia, Chad, Thailand, South Africa.
The states and territories these words name
21 states and territories.
Every one of them
- Alabama
- Arizona
- California
- Florida
- Idaho
- Illinois
- Kansas
- Kentucky
- Massachusetts
- Michigan
- Minnesota
- Mississippi
- New Jersey
- Ohio
- Pennsylvania
- South Carolina
- Tennessee
- Texas
- Virginia
- Washington
- Wisconsin
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Jun 14, 2022.
- FDA classified it on Jul 27, 2022.
- FDA’s Enforcement Report published it on Aug 3, 2022.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- SIGHT DIAGNOSTICS LTD, of Tel Aviv-Yafo, Israel.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: E-Mail.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.