{ "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": "2026-08-15", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "103543", "product_res_number": "Z-0031-2012", "event_date_initiated": "2011-08-08", "event_date_posted": "2011-10-07", "recall_status": "Terminated", "event_date_terminated": "2013-12-24", "res_event_number": "59746", "product_code": "JJE", "k_numbers": [ "K051087" ], "product_description": "Dimension Vista(R) Cuvettes \n\nThe Dimension Vista(R) Cuvettes are for use on the Dimension Vista(R) System. The Dimension Vista(R) integrated system is an in vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluid. Vista (TM) system chemical and immunochemical applications utilize photometric, turbidimetric, chemiluminescence, nephelometric and integrated ion selective multisensor technology for clinical use.", "code_info": "Catalog Number KS850 - lots: X05-076-11, X05-081-11, X05-086-11, X05-090-11, X05-091-11, X05-096-11, X05-101-11, X05-108-11, X05-117-11, X05-122-11, X05-125-11, and X05-126-11.", "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\n302-631-6311", "reason_for_recall": "Siemens Healthcare Diagnostics has confirmed a low frequency defect in the molding of the Cuvettes that may result in Cuvette Ring and Cuvette Loader jams. It \nhas been determined that the issue is related to a molding defect with the Cuvette flange or \"wing\" breaking, resulting in an error condition. Therefore, patient results are not impacted.", "root_cause_description": "Nonconforming Material/Component", "action": "Siemens Healthcare Diagnostics sent a Urgent Field Safety Notice letter dated August 2011, to all affected customers. The letter identifed the product the problem and the action needed to be taken by customer.\n\nCustomers were instructed to discard all cuvette cartridges of the identified lots. Customers were also informed that until a replacement lot is available, if an error is encountered, they may contact the Technical Solutions Center for assistance at (800) 441-9245. \n\nFor replacement product , please call the Siemens Atlanta Customer Service Center at (800) 241-0420.", "product_quantity": "1,786", "distribution_pattern": "Worldwide Distribution -- USA (nationwide) including the states of AL, AZ, CA, CO, CT, DE, FL, GA, ID, IL, IN, IA, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, OH, OK, OR, PA, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, WY and Puerto Rico., and the countries of Austria, Belgium, France, Germany, Italy, The Netherlands, Portugal, Spain, Switzerland, Australia, Japan, South Korea, and Canada.", "openfda": { "k_number": [ "K833448", "K930489", "K840868", "K760642", "K882914", "K890184", "K853699", "K950958", "K873617", "K780388", "K912024", "K840129", "K971761", "K813102", "K040958", "K863840", "K851638", "K942443", "K904219", "K963539", 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