{ "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": "106124", "product_res_number": "Z-0646-2012", "event_date_initiated": "2011-10-31", "event_date_posted": "2012-01-11", "recall_status": "Terminated", "event_date_terminated": "2013-12-24", "res_event_number": "60644", "product_code": "JJE", "k_numbers": [ "K051087" ], "product_description": "Dimension(R) Vista(R) V-LYTE(R) Diluent (K835)\n\nProduct Usage: V-LYTE(R) Diluent is for the automatic dilution of samples processed in the V-LYTE(R) Integrated Multisensor on the Dimension Vista(R) system", "code_info": "Lot number KE1H01, KE1J01, and KE1K01", "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": "Firm has confirmed that specific lots of V-LYTE(R) Fluids may contribute to reduced V-LYTE(R) Integrated Multisensor on-board use life as demonstrated by increases in: Urine sodium QC results within 48 hours after installation of a new IMT sensor. The results can be elevated approximately 10-20% which may cause QC recovery being out of acceptable ranges. Patient Urine sodium results may also b", "root_cause_description": "Material/Component Contamination", "action": "Siemens sent an Urgent Field Safety Notice letter dated October, 2011 to all consignees. The letter identified the product, description of problem, and actions to be taken. Consignees were instructed to replace the affected lots of V-LYTE(R) Fluids with alternate lots if available and recalibrate. If no alternate lots were available they were recommended to replace the V-LYTE(R) Integrated Multisensor every 24 hours or when indicated by QC until the impacted lots were no longer in use. For replacement product consignees were instructed to contact the Siemens Customer Service at 888-588-3916 or your local Siemens Service Center. Consignees were advised to complete and return the enclosed Customer Response Sheet via fax to the Technical Solutions Center at 302-631-8467. \nFor questions or concerns contact Siemens Technical Solutions Center at 800-441-9250 for further assistance.", "product_quantity": "5,282", "distribution_pattern": "Worldwide Distribution - USA (nationwide) iin the states of : AL, AZ, AR, CA, CO, CT, DE, FL, GA, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MS, MO, MT, NE, NH, NV, NJ, NM, NY, NC, OH, OK, OR, PA, SC, SD, TN, TX, VT, UT, VA, WA, WV, WI, WY including Puerto Rico and Washington, DC and the countries of: Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Italy, Netherlands, Norway, Portugal, Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Switzerland, Canada, Australia, Japan, New Zealand, Malaysia, and South Korea.", "openfda": { "k_number": [ "K873130", "K971761", "K882081", "K802609", "K840501", "K882559", "K861055", "K780083", "K840129", 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