{ "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": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "167420", "product_res_number": "Z-0218-2019", "event_date_initiated": "2018-09-17", "event_date_created": "2018-10-23", "recall_status": "Terminated", "event_date_terminated": "2020-05-18", "res_event_number": "81067", "product_code": "PPM", "product_description": "NucliSENS Magnetic Extraction Reagents", "code_info": "Reference # 200293, Lot # 17121501, Expiration date 11/28/2018", "firm_fei_number": "1000611339", "recalling_firm": "BioMerieux SA", "address_1": "Chemin De L'Orme", "city": "Marcy L'Etoile", "country": "France", "reason_for_recall": "Data loggers showed that one shipment to the United States experienced low temperatures that may impact performance of this product.", "root_cause_description": "Other", "action": "bioMerieux notified customers on about 09/17/2018 via \"URGENT PRODUCT REMOVAL NOTICE\". Instructions included the following. \n\n1. Confirm this information has been distributed to, and reviewed by, all appropriate personnel within your organization. Retain a copy of this letter for your files, and forward this information to all parties that may use this product, including others to whom you may have transferred this product. \n2. Please discontinue use and destroy any impacted product remaining in your local inventory and contact your local bioMrieux, Inc. representative for credit. \n3. Among tests previously performed with these batches, we advise you to discuss patients results: identify any possible false results, retest impacted samples when possible, analyze the related risks and determine appropriate actions if relevant. \n4. Complete the attached Acknowledgement Form in Attachment A to confirm receipt of this notice and return it to your local bioMrieux, Inc. representative. \n\nQuestions and concerns can be directed to Clinical Customer Service representative at (800) 682-2666 or Industry Customer Service representative at (800) 634-7656.", "product_quantity": "42 units", "distribution_pattern": "Nationwide distribution to MD, TX, MA, GA, OH, OR, CA, and WA.", "openfda": { "k_number": [ "K863550", "K842863", "K831619", "K842070", "K811800", "K850845", "K850916", "K811796", "K831620", "K842729", "K850737", "K871533", "K861890", "K842934", "K822326", "K822037" ], "registration_number": [ "3010692993", "3009161685", "3038196622", "2432235", "9612316", "3009547954", "3017019647", "3021269066", "2024800", "3017063217", "3005529799", "2247035", "1000391282", "1640981", "3002809144", "3029835065", "3007111389", "3035140505", "1831638", "3013059683", "3003540236", "1125908", "3007496191", "3017299606", "2242368", 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