{ "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": 43 } }, "results": [ { "cfres_id": "34915", "product_res_number": "Z-0006-05", "event_date_initiated": "2004-08-24", "event_date_posted": "2004-10-05", "recall_status": "Terminated", "event_date_terminated": "2005-07-21", "res_event_number": "29985", "product_code": "JHI", "k_numbers": [ "K935673" ], "product_description": "AxSYM Total B-hCG Reagent, Product list number: 7A59-22 and 7A59-21", "code_info": "Lot #: 18357Q100, 18357Q101 (France), 18357Q102, 18357Q103 and 18357104(France). Exp. date 11/11/04", "firm_fei_number": "2623532", "recalling_firm": "Abbott Health Products, Inc.", "address_1": "Hwy 2 Km 58.0", "city": "Barceloneta", "postal_code": "00617", "country": "PR", "additional_info_contact": "Nydia I. Cancel\n787-846-8256", "reason_for_recall": "Assay may give elevated patients results.", "root_cause_description": "Other", "action": "Device recall letters dated 8/24/2004 were sent to all customers. Customers were instructed to identify if they have used, are currently using, or have inventory of the AxSYM Total B-hCG Reagent lots. Discontinue use of and destroy any remaining inventory of the lots according to their laboratory procedures. Record the quantity currently in their facility that will be destroyed on the attached reply form and fax the form to Abbott at 1-800-777-0051 (US only). Follow their laboratory''s procedure for communicating this issue to the health care providers they serve.", "product_quantity": "7830 kits", "distribution_pattern": "Distribution was nationwide to laboratories and to the following government accounts: 375th MEDCL GRP, Scott AFB, IL, \nLogistic Div USA MEDDAC, Fort Drum, NY,\nMED MAT SVC SGSL, Colorado Springs, CO,\nNaval Hosp RCVG OFCR, Charleston, SC,\nKeller Army Hosp MED SUP, West Point, NY,\n325 MED GRP SGSL, Tyndall AFB, FL,\nVA Hosp Whse 90D, Miami, FL,\nVA MED CTR, Danville, IL,\nVA MED CTR, Amarillo, TX,\nVA MED CTR, Columbia, SC,\nVA MED CTR, Milwaukee, WI,\n1st Med GRP, Langley AFB, VA,\nVA MEDCL CTR, Charleston, SC,\nVA MEDCL CTR, Albuquerque, NM,\nUSH S IND Hosp., Lawton, OK,\nPOST MED SP HSXA LOG, Fort Belvoir, VA,\n366 MEDCL GRP SGSL, MTN HOME AFB, ID,\nDover AFB FM, Dover AFB, DE,\nWEED Army COMM Hosp, Fort Irwin, CA,\nSHAW AFB 20th MDS SGSL, Shaw AFB, SC,\nWilliam W Hasting Hosp, Tahlequah, OK,\nUSPHS San Fidel, San Fidel, NM,\nCherokee Indian Hosp, Cherokee, NC,\nMount Edgecumbe Hosp, Sitka, Ak,\nCONTR OFFICER, Lemore, CA,\nFOREST CNTY POTAWATOMI, Crandon, WI,\nNaval Hosp, Pensacola, FL,\nNaval Hosp Comm OFFR, Great Lakes, IL,\nCONTR OFFICER, Bremerton, WA,\nMEDCL CTR FED PRISIONERS, Springfield, MO,\nPHS INDIAN HOSP, Fort Yates, ND\n Foreign countries: Singapore, Australia, New Zealand, Costa Rica, Ecuador, Chile, Germany, Canada, Mexico, Barbados, St. Vincent and Bermuda.", "openfda": { "k_number": [ "K203272", "K926500", "K954993", "K033297", "K820321", "K881015", "K863861", "K781794", "K895809", "K990741", "K871700", "K951136", "K874033", "K914253", "K112315", "K012559", "K021386", "K972742", "K102175", "K812461", "K920505", "K980531", "K860542", "K013702", "K981770", "K991741", "K841023", "K955353", "K841525", "K953383", "K812156", "K830203", "K870106", "K894941", "K872130", "K010522", "K942464", "K852760", "K772039", "K881005", "K843795", "K963231", "K810215", "K003856", "K951705", 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