Class 2 Device Recall Sight OLO

• Date Initiated by Firm: January 20, 2022
• Create Date: April 21, 2022
• Recall Status: Open, Classified
• Recall Number: Z-0963-2022
• Recall Event ID: 89645
• 510(K)Number: K190898
• Product Classification: Counter, differential cell - Product Code GKZ
• Product: The Sight OLO device is a computer vision based platform for blood analysis. The platform combines computer-vision algorithms for image processing to identify and quantify blood components (e.g., red blood cells) and their characteristics (e.g., cell volume) in an automated fashion. Using dedicated staining, the proposed platform provides complete blood count analysis. The Sight OLO is a compact device, designed to be automated and simple to operate, to enable rapid testing and analysis. The Sight OLO consists of a scanning and analyzing device and a CBC test kit, including disposable cartridges and sample preparation tools. The disposable cartridge containing the blood sample is loaded into the device through the loading slot. The device is operated through the touch screen interface. The Sight OLO provides complete blood count information with 5-part differentials for white blood cell types. Specifically, the CBC parameters measured by the Sight OLO are listed below and include: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW, PLT, NEUT%/#, LYMPH %/#, MONO %/#, EO%/# and BASO%/#. In addition, the Sight OLO signals specific WBC abnormal cases by flagging the sample.
• Code Information: Software versions up to and including v2.59.3. Serial Number UDI (US): Q100 +B787OLOU10/$$+7Q-100G Q121 +B787OLOU10/$$+7Q-121J Q138 +B787OLOU10/$$+7Q-138R Q145 +B787OLOU10/$$+7Q-145P Q146 +B787OLOU10/$$+7Q-146Q Q167 +B787OLOU10/$$+7Q-167T Q212 +B787OLOU10/$$+7Q-212K Q213 +B787OLOU10/$$+7Q-213L Q225 +B787OLOU10/$$+7Q-225O Q228 +B787OLOU10/$$+7Q-228R Q241 +B787OLOU10/$$+7Q-241M Q258 +B787OLOU10/$$+7Q-258U Q264 +B787OLOU10/$$+7Q-264R Q270 +B787OLOU10/$$+7Q-270O Q273 +B787OLOU10/$$+7Q-273R Q275 +B787OLOU10/$$+7Q-275T Q277 +B787OLOU10/$$+7Q-277V Q283 +B787OLOU10/$$+7Q-283S Q303 +B787OLOU10/$$+7Q-303L Q331 +B787OLOU10/$$+7Q-331M Q332 +B787OLOU10/$$+7Q-332N Q334 +B787OLOU10/$$+7Q-334P Q338 +B787OLOU10/$$+7Q-338T Q341 +B787OLOU10/$$+7Q-341N Q347 +B787OLOU10/$$+7Q-347T Q352 +B787OLOU10/$$+7Q-352P Q363 +B787OLOU10/$$+7Q-363R Q365 +B787OLOU10/$$+7Q-365T Q372 +B787OLOU10/$$+7Q-372R Q375 +B787OLOU10/$$+7Q-375U Q380 +B787OLOU10/$$+7Q-380Q Q383 +B787OLOU10/$$+7Q-383T Q384 +B787OLOU10/$$+7Q-384U Q387 +B787OLOU10/$$+7Q-387X Q391 +B787OLOU10/$$+7Q-391S Q393 +B787OLOU10/$$+7Q-393U Q394 +B787OLOU10/$$+7Q-394V Q398 +B787OLOU10/$$+7Q-398Z Q400 +B787OLOU10/$$+7Q-400J Q403 +B787OLOU10/$$+7Q-403M Q411 +B787OLOU10/$$+7Q-411L Q417 +B787OLOU10/$$+7Q-417R Q418 +B787OLOU10/$$+7Q-418S Q420 +B787OLOU10/$$+7Q-420L Q424 +B787OLOU10/$$+7Q-424P Q427 +B787OLOU10/$$+7Q-427S Q436 +B787OLOU10/$$+7Q-436S Q437 +B787OLOU10/$$+7Q-437T Q440 +B787OLOU10/$$+7Q-440N Q442 +B787OLOU10/$$+7Q-442P Q451 +B787OLOU10/$$+7Q-451P Q452 +B787OLOU10/$$+7Q-452Q Q462 +B787OLOU10/$$+7Q-462R Q463 +B787OLOU10/$$+7Q-463S Q465 +B787OLOU10/$$+7Q-465U Q467 +B787OLOU10/$$+7Q-467W Q468 +B787OLOU10/$$+7Q-468X Q469 +B787OLOU10/$$+7Q-469Y Q470 +B787OLOU10/$$+7Q-470Q Q472 +B787OLOU10/$$+7Q-472S Q489 +B787OLOU10/$$+7Q-489- Q496 +B787OLOU10/$$+7Q-496Y Q499 +B787OLOU10/$$+7Q-499. Q510 +B787OLOU10/$$+7Q-510L Q511 +B787OLOU10/$$+7Q-511M Q512 +B787OLOU10/$$+7Q-512N Q513 +B787OLOU10/$$+7Q-513O Q515 +B787OLOU10/$$+7Q-515Q Q520 +B787OLOU10/$$+7Q-520M Q524 +B787OLOU10/$$+7Q-524Q Q527 +B787OLOU10/$$+7Q-527T Q532 +B787OLOU10/$$+7Q-532P Q534 +B787OLOU10/$$+7Q-534R Q541 +B787OLOU10/$$+7Q-541P Q543 +B787OLOU10/$$+7Q-543R Q551 +B787OLOU10/$$+7Q-551Q Q552 +B787OLOU10/$$+7Q-552R Q557 +B787OLOU10/$$+7Q-557W Q559 +B787OLOU10/$$+7Q-559Y Q561 +B787OLOU10/$$+7Q-561R Q565 +B787OLOU10/$$+7Q-565V Q569 +B787OLOU10/$$+7Q-569Z Q570 +B787OLOU10/$$+7Q-570R Q571 +B787OLOU10/$$+7Q-571S Q577 +B787OLOU10/$$+7Q-577Y Q581 +B787OLOU10/$$+7Q-581T Q586 +B787OLOU10/$$+7Q-586Y Q594 +B787OLOU10/$$+7Q-594X Q614 +B787OLOU10/$$+7Q-614Q Q620 +B787OLOU10/$$+7Q-620N Q624 +B787OLOU10/$$+7Q-624R Q633 +B787OLOU10/$$+7Q-633R Q634 +B787OLOU10/$$+7Q-634S Q638 +B787OLOU10/$$+7Q-638W Q640 +B787OLOU10/$$+7Q-640P Q659 +B787OLOU10/$$+7Q-659Z Q661 +B787OLOU10/$$+7Q-661S Q664 +B787OLOU10/$$+7Q-664V Q667 +B787OLOU10/$$+7Q-667Y Q668 +B787OLOU10/$$+7Q-668Z Q669 +B787OLOU10/$$+7Q-669- Q673 +B787OLOU10/$$+7Q-673V Q676 +B787OLOU10/$$+7Q-676Y Q678 +B787OLOU10/$$+7Q-678- Q679 +B787OLOU10/$$+7Q-679. Q681 +B787OLOU10/$$+7Q-681U Q686 +B787OLOU10/$$+7Q-686Z Q687 +B787OLOU10/$$+7Q-687- Q96 +B787OLOU10/$$+7Q-096U. Serial Number UDI (OUS) Q113 +B787OLOE10/$$+7Q-1134 Q140 +B787OLOE10/$$+7Q-1404 Q142 +B787OLOE10/$$+7Q-1426 Q157 +B787OLOE10/$$+7Q-157C Q159 +B787OLOE10/$$+7Q-159E Q162 +B787OLOE10/$$+7Q-1628 Q166 +B787OLOE10/$$+7Q-166C Q170 +B787OLOE10/$$+7Q-1707 Q175 +B787OLOE10/$$+7Q-175C Q176 +B787OLOE10/$$+7Q-176D Q177 +B787OLOE10/$$+7Q-177E Q179 +B787OLOE10/$$+7Q-179G Q180 +B787OLOE10/$$+7Q-1808 Q189 +B787OLOE10/$$+7Q-189H Q191 +B787OLOE10/$$+7Q-191A Q204 +B787OLOE10/$$+7Q-2045 Q205 +B787OLOE10/$$+7Q-2056 Q206 +B787OLOE10/$$+7Q-2067 Q208 +B787OLOE10/$$+7Q-2089 Q209 +B787OLOU10/$$+7Q-209Q Q210 +B787OLOE10/$$+7Q-2102 Q216 +B787OLOE10/$$+7Q-2168 Q220 +B787OLOE10/$$+7Q-2203 Q221 +B787OLOE10/$$+7Q-2214 Q223 +B787OLOE10/$$+7Q-2236 Q224 +B787OLOE10/$$+7Q-2247 Q227 +B787OLOE10/$$+7Q-227A Q232 +B787OLOE10/$$+7Q-2326 Q233 +B787OLOE10/$$+7Q-2337 Q234 +B787OLOE10/$$+7Q-2348 Q236 +B787OLOE10/$$+7Q-236A Q237 +B787OLOE10/$$+7Q-237B Q243 +B787OLOE10/$$+7Q-2438 Q245 +B787OLOE10/$$+7Q-245A Q246 +B787OLOE10/$$+7Q-246B Q247 +B787OLOU10/$$+7Q-247S Q249 +B787OLOE10/$$+7Q-249E Q250 +B787OLOE10/$$+7Q-2506 Q251 +B787OLOE10/$$+7Q-2517 Q255 +B787OLOE10/$$+7Q-255B Q256 +B787OLOE10/$$+7Q-256C Q260 +B787OLOE10/$$+7Q-2607 Q261 +B787OLOE10/$$+7Q-2618 Q262 +B787OLOE10/$$+7Q-2629 Q263 +B787OLOE10/$$+7Q-263A Q265 +B787OLOE10/$$+7Q-265C Q267 +B787OLOE10/$$+7Q-267E Q268 +B787OLOE10/$$+7Q-268F Q271 +B787OLOE10/$$+7Q-2719 Q272 +B787OLOE10/$$+7Q-272A Q274 +B787OLOE10/$$+7Q-274C Q276 +B787OLOE10/$$+7Q-276E Q278 +B787OLOE10/$$+7Q-278G Q279 +B787OLOE10/$$+7Q-279H Q280 +B787OLOE10/$$+7Q-2809 Q281 +B787OLOE10/$$+7Q-281A Q282 +B787OLOE10/$$+7Q-282B Q284 +B787OLOE10/$$+7Q-284D Q285 +B787OLOE10/$$+7Q-285E Q286 +B787OLOE10/$$+7Q-286F Q287 +B787OLOE10/$$+7Q-287G Q288 +B787OLOE10/$$+7Q-288H Q289 +B787OLOE10/$$+7Q-289I Q290 +B787OLOE10/$$+7Q-290A Q291 +B787OLOE10/$$+7Q-291B Q293 +B787OLOE10/$$+7Q-293D Q294 +B787OLOE10/$$+7Q-294E Q295 +B787OLOE10/$$+7Q-295F Q296 +B787OLOE10/$$+7Q-296G Q298 +B787OLOE10/$$+7Q-298I Q300 +B787OLOE10/$$+7Q-3002 Q301 +B787OLOE10/$$+7Q-3013 Q302 +B787OLOE10/$$+7Q-3024 Q304 +B787OLOE10/$$+7Q-3046 Q305 +B787OLOE10/$$+7Q-3057 Q306 +B787OLOE10/$$+7Q-3068 Q307 +B787OLOE10/$$+7Q-3079 Q308 +B787OLOE10/$$+7Q-308A Q309 +B787OLOE10/$$+7Q-309B Q313 +B787OLOE10/$$+7Q-3136 Q315 +B787OLOU10/$$+7Q-315O Q318 +B787OLOE10/$$+7Q-318B Q320 +B787OLOE10/$$+7Q-3204 Q321 +B787OLOE10/$$+7Q-3215 Q322 +B787OLOE10/$$+7Q-3226 Q323 +B787OLOE10/$$+7Q-3237 Q325 +B787OLOE10/$$+7Q-3259 Q326 +B787OLOE10/$$+7Q-326A Q327 +B787OLOE10/$$+7Q-327B Q329 +B787OLOE10/$$+7Q-329D Q330 +B787OLOE10/$$+7Q-3305 Q337 +B787OLOE10/$$+7Q-337C Q339 +B787OLOE10/$$+7Q-339E Q346 +B787OLOE10/$$+7Q-346C Q354 +B787OLOE10/$$+7Q-354B Q358 +B787OLOU10/$$+7Q-358V Q361 +B787OLOE10/$$+7Q-3619 Q366 +B787OLOE10/$$+7Q-366E Q369 +B787OLOE10/$$+7Q-369H Q371 +B787OLOE10/$$+7Q-371A Q376 +B787OLOE10/$$+7Q-376F Q379 +B787OLOE10/$$+7Q-379I Q385 +B787OLOE10/$$+7Q-385F Q386 +B787OLOE10/$$+7Q-386G Q396 +B787OLOE10/$$+7Q-396H Q401 +B787OLOE10/$$+7Q-4014 Q402 +B787OLOE10/$$+7Q-4025 Q404 +B787OLOE10/$$+7Q-4047 Q406 +B787OLOE10/$$+7Q-4069 Q407 +B787OLOE10/$$+7Q-407A Q408 +B787OLOE10/$$+7Q-408B Q409 +B787OLOE10/$$+7Q-409C Q410 +B787OLOE10/$$+7Q-4104 Q412 +B787OLOE10/$$+7Q-4126 Q413 +B787OLOE10/$$+7Q-4137 Q415 +B787OLOE10/$$+7Q-4159 Q419 +B787OLOE10/$$+7Q-419D Q421 +B787OLOE10/$$+7Q-4216 Q426 +B787OLOU10/$$+7Q-426R Q433 +B787OLOU10/$$+7Q-433P Q434 +B787OLOE10/$$+7Q-434A Q435 +B787OLOE10/$$+7Q-435B Q441 +B787OLOE10/$$+7Q-4418 Q443 +B787OLOE10/$$+7Q-443A Q445 +B787OLOE10/$$+7Q-445C Q448 +B787OLOE10/$$+7Q-448F Q454 +B787OLOE10/$$+7Q-454C Q455 +B787OLOE10/$$+7Q-455D Q457 +B787OLOE10/$$+7Q-457F Q458 +B787OLOE10/$$+7Q-458G Q460 +B787OLOE10/$$+7Q-4609 Q461 +B787OLOE10/$$+7Q-461A Q466 +B787OLOE10/$$+7Q-466F Q473 +B787OLOE10/$$+7Q-473D Q475 +B787OLOE10/$$+7Q-475F Q476 +B787OLOE10/$$+7Q-476G Q480 +B787OLOE10/$$+7Q-480B Q481 +B787OLOE10/$$+7Q-481C Q484 +B787OLOE10/$$+7Q-484F Q487 +B787OLOE10/$$+7Q-487I Q488 +B787OLOE10/$$+7Q-488J Q490 +B787OLOE10/$$+7Q-490C Q493 +B787OLOE10/$$+7Q-493F Q494 +B787OLOE10/$$+7Q-494G Q500 +B787OLOE10/$$+7Q-5004 Q503 +B787OLOE10/$$+7Q-5037 Q504 +B787OLOE10/$$+7Q-5048 Q505 +B787OLOE10/$$+7Q-5059 Q508 +B787OLOE10/$$+7Q-508C Q509 +B787OLOE10/$$+7Q-509D Q514 +B787OLOE10/$$+7Q-5149 Q516 +B787OLOE10/$$+7Q-516B Q518 +B787OLOE10/$$+7Q-518D Q519 +B787OLOE10/$$+7Q-519E Q523 +B787OLOE10/$$+7Q-5239 Q528 +B787OLOE10/$$+7Q-528E Q530 +B787OLOE10/$$+7Q-5307 Q531 +B787OLOE10/$$+7Q-5318 Q533 +B787OLOE10/$$+7Q-533A Q535 +B787OLOE10/$$+7Q-535C Q538 +B787OLOE10/$$+7Q-538F Q539 +B787OLOE10/$$+7Q-539G Q540 +B787OLOE10/$$+7Q-5408 Q546 +B787OLOE10/$$+7Q-546E Q554 +B787OLOE10/$$+7Q-554D Q556 +B787OLOE10/$$+7Q-556F Q558 +B787OLOE10/$$+7Q-558H Q560 +B787OLOE10/$$+7Q-560A Q562 +B787OLOE10/$$+7Q-562C Q563 +B787OLOE10/$$+7Q-563D Q567 +B787OLOE10/$$+7Q-567H Q572 +B787OLOE10/$$+7Q-572D Q576 +B787OLOE10/$$+7Q-576H Q578 +B787OLOE10/$$+7Q-578J Q579 +B787OLOE10/$$+7Q-579K Q584 +B787OLOE10/$$+7Q-584G Q587 +B787OLOE10/$$+7Q-587J Q588 +B787OLOE10/$$+7Q-588K Q591 +B787OLOE10/$$+7Q-591E Q600 +B787OLOE10/$$+7Q-6005 Q610 +B787OLOE10/$$+7Q-6106 Q612 +B787OLOE10/$$+7Q-6128 Q617 +B787OLOE10/$$+7Q-617D Q618 +B787OLOE10/$$+7Q-618E Q62 +B787OLOE10/$$+7Q-0627 Q621 +B787OLOE10/$$+7Q-6218 Q622 +B787OLOE10/$$+7Q-6229 Q625 +B787OLOE10/$$+7Q-625C Q629 +B787OLOE10/$$+7Q-629G Q631 +B787OLOE10/$$+7Q-6319 Q635 +B787OLOE10/$$+7Q-635D Q641 +B787OLOE10/$$+7Q-641A Q642 +B787OLOE10/$$+7Q-642B Q643 +B787OLOE10/$$+7Q-643C Q645 +B787OLOE10/$$+7Q-645E Q646 +B787OLOE10/$$+7Q-646F Q647 +B787OLOE10/$$+7Q-647G Q648 +B787OLOE10/$$+7Q-648H Q649 +B787OLOE10/$$+7Q-649I Q652 +B787OLOE10/$$+7Q-652C Q653 +B787OLOE10/$$+7Q-653D Q655 +B787OLOE10/$$+7Q-655F Q656 +B787OLOE10/$$+7Q-656G Q657 +B787OLOE10/$$+7Q-657H Q660 +B787OLOE10/$$+7Q-660B Q662 +B787OLOE10/$$+7Q-662D Q665 +B787OLOE10/$$+7Q-665G Q666 +B787OLOE10/$$+7Q-666H Q671 +B787OLOE10/$$+7Q-671D Q674 +B787OLOE10/$$+7Q-674G Q709 +B787OLOE10/$$+7Q-709F Q79 +B787OLOE10/$$+7Q-079F Q94 +B787OLOE10/$$+7Q-094C
• Recalling Firm/ Manufacturer: SIGHT DIAGNOSTICS LTD; 23, Derekh Menakhem Begin; Tel Aviv-Yafo Israel
• Manufacturer Reason for Recall: In instances where custom reference ranges were configured on the device post installation, a possibility to inadvertently apply changes to reference range values was found on software versions 2.59.3 and all earlier versions, which can potentially lead to displaying and printing incorrectly-configured reference range values
• FDA Determined Cause: Software design
• Action: Sight Diagnostics issued Medical Device Recall Notification on 1/20/22 via email to Distributors and End Users. Letter states reason for recall, health risk and action to take: In case you have configured your own reference ranges, please review the configured values to ensure all values are set properly. You can then continue to use your OLO analyzer. The software version of the OLO analyzer in your possession will be updated to a new version that resolves this software defect. The update will be performed remotely by Sights product specialists, who will contact you to schedule the update. Please be aware that the software version update requires the analyzer to be connected to the internet. If you need to make any adjustments to your reference ranges before the software update is performed, please avoid pressing the Cancel button while editing a reference range parameter, and always review all parameters after making any changes, to confirm values are set properly. If you are a distributor, please share this recall notification letter with any customer to whom the product was shipped, or may have been shipped. You are kindly requested to fill the attached Acknowledgement and Receipt Form, and return it to notifications@sightdx.com within 30 days. Software version 2.63 was released and includes the fix for the software defect mentioned above. Questions please contact us at Support@sightdx.com. For full indications for use and safety information please refer to the Quality and Compliance page at www.sightdx.com.
• Quantity in Commerce: 322 units: U.S 109 Foreign 213
• Distribution: Worldwide distribution - US Nationwide and the countries of AUSTRALIA, CANADA, CHILE, CURACAO, FINLAND, GEORGIA, GERMANY, GREECE, HONG KONG, IRELAND, ISRAEL, ITALY, MEXICO, NETHERLANDS, PORTUGAL, SINGAPORE, SLOVENIA, UNITED ARAB EMIRATES, UNITED KINGDOM.
• 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