{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-10-24", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "188581", "product_res_number": "Z-2517-2021", "event_date_initiated": "2021-03-17", "event_date_created": "2021-09-22", "recall_status": "Terminated", "event_date_terminated": "2022-06-08", "res_event_number": "88401", "product_code": "GKZ", "k_numbers": [ "K190898" ], "product_description": "Sight OLO-E1/U1 Software and Operators Manual\nSoftware v2.56.1\nCatalog #: 1 OLO-U1 \nCatalog #: 2 OLO-E1\nrevision 1.9, revision 1.10", "code_info": "Software v2.56.1\nCatalog #: 1 OLO-U1 \nCatalog #: 2 OLO-E1\nrevision 1.9, revision 1.10", "firm_fei_number": "3016099075", "recalling_firm": "SIGHT DIAGNOSTICS LTD", "address_1": "23, Derekh Menakhem Begin 23 Derekh Menakhem Begin", "city": "Tel Aviv-Yafo", "country": "Israel", "reason_for_recall": "Discrepancy in labeling between the adult CBC reference ranges presented in the OLO Operator's Manual and the OLO software", "root_cause_description": "Labeling Change Control", "action": "Sight Diagnosics issued URGENT 2021-03-16 Medical Device Recall Notification on 3/15/21 via email. Letter states reason for recall, health risk and action to take:\n\nCorrective and Preventive Actions Taken by the Company:\n Section 5.7.1 of both OLO-E1 and OLO-U1 Operator s Manuals has been updated to\nreflect the adult reference ranges verified by Sight.\n Software version v2.56.1 was updated to software version v2.56.2, which is\nconfigured (by default) with the adult reference ranges verified by Sight.\nActions to be taken by the customer:\n Please discard all previous Operator's Manuals in your possession. Attached to this\nrecall notification is the OLO Operators Manual, rev. 1.14 (U1) and 1.15 (E1). The\nupdated Operator's Manual includes Sights verified reference ranges. Each\nlaboratory should either validate these ranges or establish their own in accordance\nwith their state and regulatory agency guidelines.\n The software version of the OLO analyzer in your possession will be updated to a new\nversion that includes the above mentioned correction. The update will be performed\nremotely by Sight's product specialists, who will contact you in the coming month to\nschedule the update. Please be aware that the software version update requires the\nanalyzer to be connected to the internet.\n If you are a distributor, please provide a copy of this recall notification and updated\nOperator s Manual to any customer whom the product was shipped to, or may have\nbeen shipped to. If you have been authorised by Sight to translate the Operator s\nManual, please make sure you update the Operator s Manual s translation\naccordingly.\n You are kindly requested to fill the attached Acknowledgement and Receipt Form,\nand return it to Sight notifications@sightdx.com within 30 days.\n If you are required to notify your local authority, please use this notification letter\nand inform Sight as soon as possible.\n\nIf you have any questions please contact us at Support@sightdx.com. For full indicati", "product_quantity": "114 units", "distribution_pattern": "Worldwide distribution - US Nationwide distribution in the states of Alabama, Florida, \nMassachusetts, Minnesota, Missouri, New York, Ohio, Texas, Virginia, Washington and the countries of AUSTRALIA, CHILE, UNITED KINGDOM, GEORGIA, ISRAEL, Mexico, \nNETHERLANDS, Portugal, Russia, Singapore, Thailand.", "openfda": { "k_number": [ "K992875", "K925274", "K770701", "K160429", "K162414", "K032000", "K081890", "K926124", "K081213", "K222148", "K943967", "K250943", "K071562", "K800533", "K953643", "K920544", "K022161", "K982231", "K855116", "K904253", "K953116", "K874147", "K770550", "K022668", "K260781", "K855117", "K883177", "K904390", "K911385", "K922704", "K951100", "K932030", "K914014", "K964618", "K944128", "K950919", "K944253", "K083420", "K052905", "K022528", "K190294", "K891276", "K990172", "K061150", "K950626", "K925344", "K041882", "K925528", "K882557", "K852371", "K922085", "K974360", "K914744", 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"3002808301", "3013059683", "2182501", "2914537", "3003630693", "3010324880", "1832816", "3002759288", "3009156722", "3008425728", "3005333358", "3009711478", "3013608230", "3006412379", "3016438761", "3003071743", "3009092698", "3010960914", "1415939", "3020704087", "3003601075", "1000442352", "3002807272", "3007349751" ], "device_name": "Counter, Differential Cell", "medical_specialty_description": "Hematology", "regulation_number": "864.5220", "device_class": "2" } } ] }