{ "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": 1 } }, "results": [ { "cfres_id": "103938", "product_res_number": "Z-0038-2012", "event_date_initiated": "2011-08-31", "event_date_posted": "2011-10-12", "recall_status": "Terminated", "event_date_terminated": "2013-05-20", "res_event_number": "59888", "product_code": "JJE", "k_numbers": [ "K081683" ], "product_description": "Dimension(R) EXL LOCI Cardiac Troponin I Calibrator (RC621)\n\nThe LOCI Cardiac TNI Calibrator is an in vitro diagnostic product for the calibration on Cardiac Troponin I method on the Dimension(R) EXL (TM) Integrated chemistry system with LOCI(R) module.", "code_info": "Lot Number 1AD045", "firm_fei_number": "2517506", "recalling_firm": "Siemens Healthcare Diagnostics, Inc.", "address_1": "500 GBC Drive, Mailstop 514 500 GBC Drive Mailstop 514", "address_2": "PO BOX 6101", "city": "Newark", "state": "DE", "postal_code": "19714-6101", "additional_info_contact": "Robert J. King\n302-631-0516", "reason_for_recall": "Internal testing has confirmed that recovery of levels 2 and 3 of LOCl Cardiac Troponin I Calibrator is lower than expected bottle value. Following calibration with LOCl Cardiac Troponin I Calibrator, lot 1AD045 an upward shift in patient and QC results may be observed.", "root_cause_description": "Other", "action": "Siemens sent an Urgent Field Safety Notice dated August 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately discontinue use and discard any remaining inventory. Replacement orders would be processed and sent free of charge. Customers were also instructed to complete the attached FIELD CORRECTION EFFECTIVENESS CHECK form and fax it to (302) 631- 8457.\nCustomers were instructed to forward the Safety Notice to anyone to whom they may have distributed the affected product. \nFor any technical questions customers were to contact the Siemens Solutions Center at 800-441-9250.", "product_quantity": "998", "distribution_pattern": "Worldwide Distribution - USA (nationwide) including AL, AK, AZ, AR, CA, CO, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NM, NY, NC, OH, OK, OR, PA, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, and WY and the countries of GUAM, Austria, Canada, China, Czech Republic, Egypt, France, Germany, Italy, Poland, Portugal, Puerto Rico, Spain and Switzerland.", "openfda": { "k_number": [ "K130915", "K946090", "K833067", "K920402", "K904219", "K830212", "K945271", "K831477", "K843059", "K945135", "K790072", "K883209", "K073370", "K772319", "K910185", "K961481", 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