{ "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": "2026-08-27", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "204977", "product_res_number": "Z-0712-2024", "event_date_initiated": "2023-11-21", "event_date_posted": "2024-01-11", "recall_status": "Open, Classified", "res_event_number": "93621", "product_code": "JIT", "k_numbers": [ "K123343" ], "product_description": "QMS Tacrolimus Calibrators, Product code 10015573", "code_info": "No UDI\n\nLot 74859619, Expiry 11-May-2024", "firm_fei_number": "1000136573", "recalling_firm": "Ortho-Clinical Diagnostics, Inc.", "address_1": "100 Indigo Creek Dr", "city": "Rochester", "state": "NY", "postal_code": "14626-5101", "additional_info_contact": "Mr. Joe Falvo\n585-453-3000", "reason_for_recall": "Ortho-Clinical Diagnostics, Inc. is recalling QMS Tacrolimus Calibrators, Lot 74859619 expiry date: May 11, 2024, due to improper storage that is expected to degrade the quality of the calibrator and render it unsuitable for use. Use of the affected lot may results in erroneous calibration results, causing delay in testing.", "root_cause_description": "Storage", "action": "On 21 November 2023, all consignees who were shipped the VITROS QMS Tacrolimus Calibrators Lot 74859619 expiry date: 11-May-2024 from QuidelOrtho distribution center were notified of the issue and instructed to:\n\n-Discontinue using, render unusable, and discard your inventory of QMS Tacrolimus Calibrators, Lot 74859619, which was shipped to the laboratory from QuidelOrtho.\n\n-Post the notification by the laboratory s inventory storage area until a replacement lot of QMS Tacrolimus Calibrator has been received.\n\n-Forward the notification if the affected product was distributed outside their facility.\n\nIf you have questions about this recall, please contact QuidelOrtho's Global Services Organization (formerly Ortho Care) at 1-800-421-3311.", "product_quantity": "10 sales units US; 1 sales unit OUS", "distribution_pattern": "Domestic distribution to IL, IN, FL, NJ, NM, TX. International distribution to Chile.", "openfda": { "k_number": [ "K983722", "K800770", "K882259", "K772153", "K844047", "K861314", "K061139", "K770126", "K021535", "K060322", "K871763", "K143144", "K973100", "K031159", "K895648", "K030772", "K043095", "K871762", "K003096", "K130628", "K944516", "K140112", "K040692", "K823019", "K872073", "K103221", "K844468", "K964368", "K050231", "K871150", "K042521", "K771216", "K012399", "K963493", "K012367", "K111023", "K082680", "K053291", "K132400", "K061702", "K872263", "K823020", "K163546", "K871758", "K093357", "K981854", "K842099", "K052002", "K060140", "K142181", "K884197", "K061885", "K983548", "K871765", "K060854", "K840772", "K853887", "K152526", "K851670", "K871756", "K822479", "K010314", "K882059", "K891999", "K072717", "K133751", "K970389", "K802823", "K060359", "K040226", "K981100", "K994291", "K771802", "K990554", "K781069", "K153417", "K840775", "K103548", "K823025", "K832094", "K862525", "K103836", "K970336", "K833702", "K993132", 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"3002676602", "1000305840", "3005622096", "3003982601", "3005847079", "1000119795" ], "device_name": "Calibrator, Secondary", "medical_specialty_description": "Clinical Chemistry", "regulation_number": "862.1150", "device_class": "2" } } ] }