{ "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": "207976", "product_res_number": "Z-2173-2024", "event_date_initiated": "2024-05-13", "event_date_posted": "2024-06-21", "recall_status": "Open, Classified", "res_event_number": "94678", "product_code": "GKZ", "k_numbers": [ "K190898", "K211840" ], "product_description": "Sight OLO CBC Test Kit, Model/Catalog Number: TK1. A disposable cartridge and sample preparation tools for use with the Sight OLO CBC analyzer.", "code_info": "REF: TK1, UDI-DI: B787TK10, Lot Code: 10114", "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", "additional_info_contact": "Customer Support\n1-833-7444839 Ext. 3", "reason_for_recall": "One Test Kit lot (TK1-10114) shows a positive bias in the platelet count due to bacterial contamination which can result in elevated counts with a bias of 7.5 k/ul. This results in the test kit lot performing outside of the device specification.", "root_cause_description": "Process control", "action": "On May 15, 2024, URGENT Medical Device Recall letters were sent to customers. Following identification of the affected lot units, please take the following action:\n1. Please discontinue use and quarantine any product from Lot 10114.\n2. Return any unused units of test kit Lot 10114 to the company or discard them\nimmediately according to standard practice.\nNOTE: For return of unused test kits please indicate so in the acknowledgement and\nreceipt form and Customer Support will contact you with further instructions. 3. Review previously obtained test results conducted with the affected lot and identify\npopulations at higher risk. Retest if necessary.\nNOTE: If you require assistance in identifying samples tested using the affected lot\nplease indicate so in the acknowledgment and receipt form and we will be happy to\nprovide you with any necessary information.\n4. If you are a distributor, please share this notification with any customer to whom the\nproduct was shipped, or may have been shipped.\n5. You are kindly requested to fill out the attached Acknowledgement and Receipt Form\nand return it to Sight as soon as possible, and in any case no later than 30 days from\nthe date of this notification, via email, to notifications@sightdx.com. Please provide\nthe form even if you no longer have any product in inventory so that we can verify\nthat all affected product has been removed.\n6. If you are required to notify your local authority please use this notification and notify Sight as soon as possible. We appreciate your time and apologize for any inconvenience this may have caused. Please\ndo not hesitate to reach out with any questions or feedback to Customer Support via the\nfollowing channels:\nUS Customers\nOLOsupport@sightdx.com\nCallback service (voicemail) +1-833-SIGHTDX (7444839 ext. 3)\nText +1 617 4105226\nPartners (Distributors)\nsupport@sightdx.com\nCallback service (voicemail) +44 0203 093 0772 (ext. 2)\nText +44 7449 063724\nCustomer Support is available Mon-Fri EST- 2:00AM-7:00", "product_quantity": "7,450 units (2,800 US, 4,650 OUS)", "distribution_pattern": "Worldwide - US Nationwide distribution in the states of AL, FL, MS, TX, WI and the countries of Canada, Israel, Slovenia, Trinidad & Tobago.", "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", 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