Recall Z-1469-2022
Sight Diagnostics Ltd · initiated June 14, 2022
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Sight OLO, Automated Hematology Analyzer, Catalog No. OLO-U1
Codes / lots: 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…
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: Software Design Change
Action taken
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.
Details
- Recall number
- Z-1469-2022
- Initiated
- June 14, 2022
- Product code
- GKZ – Counter, Differential Cell
- Quantity
- 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…
- Recalling firm
- Sight Diagnostics Ltd, Tel Aviv-Yafo