{ "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": "2026-08-15", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "90278", "product_res_number": "Z-0107-2011", "event_date_initiated": "2010-03-04", "event_date_posted": "2010-10-20", "recall_status": "Terminated", "event_date_terminated": "2012-04-27", "res_event_number": "55195", "product_code": "CEW", "k_numbers": [ "K952199" ], "product_description": "Active I-PTH Enzyme-Linked Immunosorbent Assay(ELISA), Part Number: DSL-10-8000\nThe DSL-10-8000 ACTIVE I-PTH Enzyme-Linked Immunosorbent Assay (ELISA) Kit provides materials for the quantitative measurement of I-PTH in serum or plasma. This assay is intended for in vitro diagnostic use as an aid in the diagnosis of hyperparathyroidism", "code_info": "Lot Numbers: 891198, 990980, 991448", "firm_fei_number": "2050012", "recalling_firm": "Beckman Coulter Inc.", "address_1": "200 S Kraemer Blvd", "city": "Brea", "state": "CA", "postal_code": "92821-6208", "additional_info_contact": "Clair K. ODonovan, Ph.D.\n714-993-5321", "reason_for_recall": "The recall was initiated after Beckman Coulter confirmed that the stated stability of the DSL-10-8000 I-PTH ELISA assay may\nnot be achieved for lot numbers: 891198, 990980 and 991448.\nThe kit lot numbers listed above passed the stability testing performed at 6 months, but failed the testing performed at 12 months. Therefore the affected I-PTH ELISA kit lots may produce falsely elevated patient r", "root_cause_description": "Other", "action": "Beckman Coulter sent an URGENT: PRODUCT CORRECTIVE ACTION letter dated March 17, 2010 with attached Customer Response form to all customers who received Active I-PTH ELISA kits with the affected lot numbers. The letter identified the product, the problem, and the actions to be taken.\n\nCustomers were instructed to:\n(1) Discontinue use of all materials provided with I-PTH ELISA kit lot numbers 891198, 990980 and 991448;\n(2) Review historical external quality control results to ensure the assay performance of these lots was within laboratory specifications. Retesting may be necessary if your laboratory uses only the control materials provided with the I-PTH ELISA kit;\n(3) Abnormally elevated patient results that are obtained with these lot numbers and that are inconsistent with the patient's clinical status should be reviewed in the context of other clinical\ndiagnostic tests; \n(4) I-PTH ELISA kit lot numbers 891198, 990980 and 991448 will no longer be shipped.\nAlternate lots will be provided for current and future replenishment orders or requests.\nin addition customers were instructed to share this information with your laboratory staff and retain this notification as part of your\nlaboratory Quality System documentation. Complete and return the enclosed response form within 10 days.\nFor questions regarding this recall contact (800) 231-7970.", "product_quantity": "70 kits", "distribution_pattern": "Nationwide Distribution including the states of CA, CT, IA, IL, MI, NY, SC, and TX", "openfda": { "k_number": [ "K811418", "K861797", "K133601", "K840379", "K944788", "K022603", "K232791", "K033727", "K874299", "K843870", "K001411", "K051810", "K011505", "K000471", "K150879", "K221197", "K013566", "K053533", "K843685", "K901711", "K020945", "K844735", "K771783", "K161158", "K821131", "K974306", "K101921", "K962598", "K992680", "K051141", "K022472", "K051150", "K060420", "K962033", "K132515", "K850254", "K942369", "K950211", "K853784", "K896294", "K004038", "K033426", "K992105", "K163658", "K031534", "K831470", "K070391", "K930008", "K822944", "K952199", "K843871", "K973514", "K013992", "K040813", "K051888", "K061190", "K103325", "K060348", "K820228", "K831069", "K903130", "K033302", "K813203", "K063232", "K921949", "K121981", "K830700", "K070709", "K782010", "K830664", "K791128", "K063605", "K882560", "K782081", "K970483", "K954418", "K921629", "K941878", "K833768", "K934760", "K231927", "K913434", "K772249", "K811566", "K190702", "K871970" ], "registration_number": [ "1036362", "3033967997", "2122870", "3009518015", "9612316", "3007118747", "2245285", "2182595", "3005529799", "3002809144", "2025099", "1222302", "2432235", "8021924", "9610126", "3022178699", "8023018", "3012963943", "3011989923", "3007111389", "1219913", "8031673", "1319681", "9610746", "3002642396", "8020888", "3000308930", "2250051", "3002800697", "2020726", "3005333358", "2032839", "9680746", "2517506", "3002806944", "3006198300" ], "fei_number": [ "3002806557", "1036362", "3033967997", "3002485711", "3002808328", "2122870", "3009518015", "3007118747", "2967", "2245285", "3002807272", "2182595", "3007019572", "3005529799", "3002809144", "2432235", "3004185580", "3007981058", "3022178699", "1000206808", "3012963943", "3011989923", "3007111389", "1219913", "3002642396", "3000308930", "2250051", "3002800697", "2020726", "3005333358", "1000121039", "1000136573", "2517506", "3002806944", "3006198300", "3002806559" ], "device_name": "Radioimmunoassay, Parathyroid Hormone", "medical_specialty_description": "Clinical Chemistry", "regulation_number": "862.1545", "device_class": "2" } } ] }