{ "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": "2026-09-10", "results": { "skip": 0, "limit": 1, "total": 3 } }, "results": [ { "cfres_id": "193234", "product_res_number": "Z-1112-2022", "event_date_initiated": "2022-03-25", "event_date_created": "2022-05-18", "recall_status": "Open, Classified", "res_event_number": "90047", "product_code": "CGJ", "k_numbers": [ "K964720" ], "product_description": "VITROS Immunodiagnostic Products FSH Reagent Pack- IVD\n1931922", "code_info": "Until further notice, future lots will also be affected.\n\nUDI: 10758750000302\nAffected Lot Number/ Expiration Date:\n3100 01-MAR-2022;\n3111 25-MAR-2022;\n3120 04-APR-2022;\n3130 25-APR-2022;\n3140 10-MAY-2022;\n3145 10-MAY-2022;\n3150 30-MAY-2022;\n3160 09-JUN-2022;\n3170 22-JUN-2022; \n3180 02-AUG-2022;\n3190 16-AUG-2022;\n3200 06-SEP-2022;\n3210 12-SEP-2022.", "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": "Falsely high or delayed patient and QC results may occur due to low end imprecision. VITROS Immunodiagnostic Products FSH, LH and Prol Reagents Low End Imprecision. Low-level quality control (QC) and patient samples at the low end of the Measuring (Reportable) Range when using VITROS FSH, LH and Prol Reagent. Calibration failures, driven by imprecision observed with Calibrator Level 1.", "root_cause_description": "Device Design", "action": "Ortho CLinical Diagnostics issued \"URGENT PRODUCT CORRECTION NOTIFICATION\" dated 3/25/22 to consignees who had been shipped VITROS FSH, LH or Prol in the previous 18 months were notified (CL2022-069) of the issue and instructed as follows:\n-Run daily low-level QC in duplicate to confirm acceptable performance.\n-If their laboratory is experiencing low end imprecision with VITROS FSH, LH or Prol Reagent, follow one of the suggested testing algorithms as described in the enclosure.\no Note: If their laboratory is not experiencing low end imprecision, continue testing patient samples as usual (single replicate).\n-Until further notice, all future lots of the products will also be affected. \n-On the enclosed Credit Form, track the additional quantities of VITROS FSH, LH and/or Prol tests used due to the testing protocol. Periodically submit the form to Ortho. Ortho will credit their account. \n\nIf you have further questions, please contact Ortho Care Technical Solutions Center at 1-800-421-3311.", "product_quantity": "2502 total: 2154\tUS; 348 OUS", "distribution_pattern": "Worldwide Distribution:\nUS (Nationwide)\nOUS (Foreign):\nAustralia\nBermuda\nBrazil\nCanada L3R 4G5 \nChile\nChina\nColombia\nDenmark\nFrance\nGermany\nIndia\nItaly\nJapan\nMexico\nNetherlands\nNorway\nPortugal\nRussia\nSingapore \nSpain\nSweden\nUnited Kingdom", "openfda": { "k_number": [ "K881123", "K895108", "K052662", "K881596", "K834038", "K863678", "K905814", "K851361", "K820048", "K935612", "K883745", "K890135", "K896640", "K895005", "K854651", "K820740", "K843930", "K864080", "K854837", "K900763", "K893976", "K771756", "K873051", "K970085", "K904649", "K791836", "K862439", "K915208", "K872309", "K883305", "K821611", "K822227", "K883279", "K921704", "K930304", "K760373", "K040575", "K831742", "K896864", "K894761", "K820358", "K842444", "K941221", "K922376", "K820754", "K911409", "K972720", "K863928", "K002450", "K810663", "K813086", "K905592", "K870520", "K043599", "K810852", "K862043", "K800107", "K823379", "K871317", "K840230", "K964720", "K792063", "K912804", "K780870", "K884708", "K030058", "K962118", "K921746", "K892706", "K884687", "K792233", "K872627", "K041165", "K964693", "K862813", "K833852", "K881142", "K803279", "K810381", "K920917", "K904405", "K811993", "K940005", "K844066", "K811905", "K952285", "K943437", "K901345" ], "device_name": "Radioimmunoassay, Follicle-Stimulating Hormone", "medical_specialty_description": "Clinical Chemistry", "regulation_number": "862.1300", "device_class": "1", "registration_number": [ "1827821", "3005529799", "3009092698", "3031915160", "3005333358", "3017379203", "9612316", "2245285", "3009984016", "1319681", "3007113174", "3004434309", "3047746876", "2031229", "8020790", "1832216", "2250051", "3012963943", "3017894300", "9610240", "3007111389", "3003741796", "2032682", "1319436", "3011989923", "3002642396", "2122870", "2517506", "1036362", "2020726", "1222302", "3033967997", "3005094123", "3007349751", "8031673", "2432235", "3002809144", "2029372", "3009491259", "3005984081", "3006198300", "3002806944", "2032839", "8020888", "1219913", "3017019647", "3008198807", "3004192065", "3002800697", "9680746", "8010132", "3000308930", "3022178699", "9610126" ], "fei_number": [ "1827821", "3005529799", "3009092698", "3031915160", "3005333358", "1000120319", "1000306617", "3017379203", "3007019572", "2245285", "3002806559", "3009984016", "1000206808", "3007113174", "3004434309", "3002806808", "3047746876", "1832216", "2250051", "3012963943", "1000121039", "3017894300", "3007111389", "3004185580", "3003741796", "1000136573", "3000719950", "3011989923", "3002642396", "2122870", "1000611339", "2517506", "1036362", "3002808212", "3003952975", "2020726", "3033967997", "3005094123", "3007349751", "2432235", "3002809144", "3009491259", "3005984081", "3006198300", "3002806944", "3002808328", "1219913", "3017019647", "3008198807", "3004192065", "3002800697", "2967", "3000308930", "3022178699" ] } } ] }