{ "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": "130155", "product_res_number": "Z-0214-2015", "event_date_initiated": "2014-09-12", "event_date_posted": "2014-11-14", "recall_status": "Terminated", "event_date_terminated": "2015-07-17", "res_event_number": "69282", "product_code": "JJE", "product_description": "ADVIA Centaur and ADVIA Centaur XP and ADVIA Centaur CP Cleaning Solution (For in vitro diagnostic use with the ADVIA Centaur systems)\nCatalog Number: 112748\n(Siemens Material Number (SMN): 10310041\n\nThe Cleaning Solution is a component of the ADVIA Centaur and ADVIA Centaur XP and ADVIA Centaur CP instruments, and therefore does not have independent Instructions for Use (IFU). Information regarding use of the Cleaning Solution is contained in the owner's manual for the instruments.", "code_info": "Lot Numbers: 459356 Exp. Date: November 2014; 443105 Exp. Date: November 2014", "firm_fei_number": "1219913", "recalling_firm": "Siemens Healthcare Diagnostics, Inc", "address_1": "333 Coney St", "city": "East Walpole", "state": "MA", "postal_code": "02032-1516", "additional_info_contact": "508-668-5000", "reason_for_recall": "Stability of the ADVIA Centaur Cleaning Solution is not assured", "root_cause_description": "Material/Component Contamination", "action": "Siemens issued an Urgent Medical Device Recall (UMDR) to customers in the US on September 12, 2014. An Urgent Field Safety Notice (UFSN) was sent out for distribution to all customers outside the United States on September 12, 2014. These notices inform the customer of the degradation of hypochlorite in\nthese lots of cleaning solution. Customers were instructed to discontinue use of the affected lots and dispose of the product according to local regulations or procedures. The notices should be reviewed with the facility's laboratory or medical director. Fax-back forms will be used to confirm that the customers received the UMDR. For those customers that do not return a fax-back form, a Siemens representative will follow up with those customers to ensure they received the Urgent Medical Device Recall\nFor questions regarding this recall call 508-668-5000.", "product_quantity": "4645 (12 pk)", "distribution_pattern": "Worldwide Distribution - USA (nationwide) and Internationally to Canada. 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