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U.S. Department of Health and Human Services

Class 2 Device Recall Sight OLO

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  Class 2 Device Recall Sight OLO see related information
Date Initiated by Firm June 14, 2022
Create Date July 27, 2022
Recall Status1 Open3, Classified
Recall Number Z-1469-2022
Recall Event ID 90533
510(K)Number K190898  
Product Classification Counter, differential cell - Product Code GKZ
Product Sight OLO, Automated Hematology Analyzer, Catalog No. OLO-U1
Code Information 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
Recalling Firm/
Manufacturer		 SIGHT DIAGNOSTICS LTD
23, Derekh Menakhem Begin
Tel Aviv-Yafo Israel
Manufacturer Reason
for Recall		 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 Determined
Cause 2		 Software Design Change
Action On June 14, 2022, the firm notified customers via email of the recall. Customers were informed that a software correction for this issue will be included in any software version ABOVE 2.63.1.1. Pending the software correction through a version upgrade, the firm provided instructions to manually configure the correct default reference ranges on the device, which are also included in Section 2.5.4 of the Sight OLO Operator's Manual. Alternatively, you can contact support@sightdx.com and coordinate a time for Sight's technical support team to remotely update your device software.
Quantity in Commerce 72 US; 292 OUS
Distribution 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = GKZ and Original Applicant = Sight Diagnostics Ltd.
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