{ "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": 571 } }, "results": [ { "cfres_id": "112305", "product_res_number": "Z-0023-2013", "event_date_initiated": "2012-08-28", "event_date_posted": "2012-10-09", "recall_status": "Terminated", "event_date_terminated": "2014-09-04", "res_event_number": "63019", "product_code": "LXG", "product_description": "PREVI Isola System, Catalog numbers 29500 and 29500R, bioMerieux, Inc., Durham, NC.\n\nIntended to perform the inoculation and streaking of Prepoured Media (PPM) with liquid microbiological samples.", "code_info": "Serial numbers AS180-00001 to AS180-00376.", "firm_fei_number": "1950204", "recalling_firm": "Biomerieux Inc", "address_1": "595 Anglum Rd", "city": "Hazelwood", "state": "MO", "postal_code": "63042-2320", "additional_info_contact": "Ryan LeMelle\n314-731-8582", "reason_for_recall": "The instrument may not dispense the specimen onto the pre-poured media resulting in a false negative result.", "root_cause_description": "Labeling design", "action": "bioMerieux sent an \"URGENT PRODUCT CORRECTION NOTICE\" letter dated August 28, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. An Acknowledgement Form was included for customers to complete and return. Contact Customer Service at 1-800-682-2666 for questions regarding this notice.", "product_quantity": "350 systems", "distribution_pattern": "Worldwide Distribution-USA (nationwide)-including DC and the states of CA, CO, CT, FL, GA, IL, IN, KY, LA, MO, NC, NJ, NY, OH, OR, PA, RI, SC, TX, and WI, and the country of Canada.", "openfda": { "k_number": [ "K021927", "K943466", "K896802" ], "registration_number": [ "", "3007648367", "3012104009", "3043153468", "2182595", "3014437893", "3019837962", "3003423869", "3013530901", "1063851", "9613910", "3043127699", "1317188", "3020704087", "1211566", "2083595", "8020301", "9616119", "3018771894", "3011258423", "3010402964", "3017450368", "3010891909", "3016764932", "3016763307", "3014255036", "3042244574", "9610942", "3007361513", "3000682787", "3008349578", "3010131137", "3009420598", "3032023483", "1417592", "3009731198", "9616088", "9680244", "1423537", "1220502", "3010386080", "3008925277", "8020790", "3009711478", "3010188766", "1319681", 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