{ "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": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "196591", "product_res_number": "Z-0220-2023", "event_date_initiated": "2022-10-13", "event_date_posted": "2022-11-10", "recall_status": "Open, Classified", "res_event_number": "91051", "product_code": "DKB", "product_description": "VITROS Chemistry Products Calibrator Kit 9 -(GEN) 22 of VITROS PHYT Slides\nFor in vitro diagnostic use only.\nProduct Code: 8568040\n\n.\nVITROS Chemistry Products Calibrator Kit 9 is used to calibrate VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems for the quantitative measurement of ACET, CRBM, DGXN, PHBR, and PHYT", "code_info": "UDI-DI: 10758750005031\nKit Lots/Exp. Date:\n0911 24-MAY-2023;\n0921 04-OCT-2023;\n0942 06-JUN-2024;\n0980 26-OCT-2022;\n0991 01-MAR-2023\n \nVITROS Chemistry Products PHYT Slides, GEN 22, All lots\n\nCalibration Diskette Data Release Versions (DRVs) 6194 through 6200 supporting VITROS Calibrator Kit 9.", "firm_fei_number": "2250051", "recalling_firm": "Ortho-Clinical Diagnostics, Inc.", "address_1": "1001 Us Highway 202", "city": "Raritan", "state": "NJ", "postal_code": "08869-1424", "additional_info_contact": "SAME\n908-218-8776", "reason_for_recall": "Calibration disk Data Release Version (DRV) 6194 to 6200 contain inappropriate calibration mathematics for VITROS Calibration Kit 9 for calibrating VITROS PHYT Slides, for\nall lots of slide generation 22 (GEN 22). The erroneous mathematics on the calibration disk prevents the VITROS 250/350 Chemistry System from successfully calibrating, leading to delayed results.", "root_cause_description": "Under Investigation by firm", "action": "Ortho Clinical Diagnostics issued Urgent Letter (CL2022-260) to VITROS 250/350 Chemistry System consignees. Letter states reason for recall, health risk and action to take:\nUpon receiving this communication, load Calibration Diskette DRV 6201 on your VITROS 250/350 Chemistry System and calibrate VITROS PHYT Slides, GEN 22 using VITROS Calibrator Kit 9.\nComplete the enclosed Confirmation of Receipt form no later than October 21, 2022.\nPlease forward this notification if the affected product was distributed outside of your facility.\n Save this notification with your user documentation or post this notification by each VITROS 250/350 Chemistry System until Calibration Diskette DRV 6201 has been received and loaded by your facility.\n If your laboratory has experienced the issue with this product and you have not already done so, please report the occurrence to your local Ortho Care\" Technical Solutions Center.\n\nIf you have further questions, please contact the Ortho Care Technical Solutions Center at 1-800-421-3311", "product_quantity": "17,396 Units", "distribution_pattern": "Worldwide Distribution: US (Nationwide) and Countries (Foreign) including:\nAustralia\nBermuda DV04\nBermuda, HM 13\nBermuda, HM08\nBrazil\nCanada L3R 4G5 \nChile\nChina\nColombia\nDenmark\nFrance\nGermany\nIndia\nItaly\nJapan\nMexico\nNorway\nPortugal\nRussia\nSingapore 609917\nSpain\nSweden\nUnited Kingdom", "openfda": { "k_number": [ "K901573", "K875216", "K811674", "K872392", "K060645", "K884177", "K811620", "K120936", "K913740", "K961372", "K802624", "K843507", "K904764", "K821767", "K920208", "K894934", "K935794", "K990255", "K961273", "K910085", "K993755", "K101752", "K981403", "K062121", "K974699", "K810464", "K820190", "K133710", "K790735", "K843163", "K033879", "K962817", "K936028", "K881320", "K913335", "K881943", "K893815", "K945289", "K971287", "K842386", "K012318", "K902581", "K842816", "K090900", "K820461", "K983209", "K880705", "K902578", "K931124", "K971600", "K954608", "K092266", "K910087", "K833276", "K932754", "K862403", "K062162", "K913739", "K032574", "K834398", "K993954", "K033306", "K935101", "K913741", "K823740", "K935192", "K910881", "K935550", "K013959", "K963191", "K031775", "K905828", "K935793", "K871174", "K980853", "K923340", "K982871", "K903152", "K942048", "K983159", "K031856", "K141928", "K892332", "K932753", "K912729", "K940935", "K090939", "K833761", "K983747", "K021393", "K051088", "K915003", "K950139", "K935792" ], "registration_number": [ "2050012", "3004493545", "3012963943", "1616487", "3003610499", "1319681", "1319808", "2050010", "3002809144", "2020952", "9610126", "2250051", "1827821", "2517506", "1219913", "3003795116", "2030861", "3003593973", "8020888", "3002642396", "3005333358", "3017181603", "3033967997", "2432235", "3000308930", "3006198300", "9610529", "3010939897" ], "fei_number": [ "2050012", "3004493545", "3012963943", "1616487", "3003610499", "2050010", "3002809144", "3002806560", "2020952", "2250051", "1827821", "3002806559", "2517506", "1219913", "3003795116", "1000305841", "1000136573", "3000215862", "3003593973", "3002642396", "3005333358", "3017181603", "3033967997", "3007019572", "2432235", "3000308930", "3006198300", "3010939897" ], "device_name": "Calibrators, Drug Mixture", "medical_specialty_description": "Clinical Toxicology", "regulation_number": "862.3200", "device_class": "2" } } ] }