{ "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": "2026-09-10", "results": { "skip": 0, "limit": 1, "total": 20 } }, "results": [ { "cfres_id": "186154", "product_res_number": "Z-1386-2021", "event_date_initiated": "2021-03-05", "event_date_created": "2021-04-09", "recall_status": "Open, Classified", "res_event_number": "87488", "product_code": "GKZ", "k_numbers": [ "K102644", "K162977" ], "product_description": "ADVIA 2120 with Single Aspirate Autosampler (SMN 10316162) - US, automated hematology analyzer\nSoftware Versions 6.10 and 6.11", "code_info": "Software Versions 6.10 and 6.11  UDI: 00630414501208", "firm_fei_number": "2432235", "recalling_firm": "Siemens Healthcare Diagnostics, Inc.", "address_1": "511 Benedict Ave", "city": "Tarrytown", "state": "NY", "postal_code": "10591-5005", "additional_info_contact": "SAME\n914-631-8000", "reason_for_recall": "Potential Sample Identification (SID) Mismatch with14-Character Barcodes", "root_cause_description": "Under Investigation by firm", "action": "Siemens Healthcare Diagnostics issued Urgent Medical Device Correction (UMDC) letter HSW21-01.A.US to US customers on March 5, 2021 via FedEx overnight delivery. An Urgent Field Safety Notice (UFSN) HSW21-01.A.OUS was issued to all OUS Siemens sites with affected customers electronically for distribution and regional reporting to their local competent authorities.\nLetter states reason for recall, health risk and action to take:\nwith your Medical Director.\nIf you are using 14-character Sample Identification (SID) barcodes:\no Ensure that the Barcode Encoding Selectivity feature is enabled.\n Open the Sample Identification screen to determine if the checkbox to turn the Barcode Encoded Selectivity is on\no If Barcode Encoding Selectivity is disabled, please perform the following steps to enable Barcode Encoding Selectivity:\n Open the Sample Identification screen\nSelect the checkbox to turn the Barcode Encoded Selectivity on\nWhether or not you have the Barcode Encode Selectivity feature disabled, please complete and return the Field Correction Effectiveness Check Form attached to this letter within 30 days. Please retain this letter with your laboratory records and forward this letter to those who may have received this product\n\nIf you have any questions, please contact your Siemens Healthineers Customer Care Center or your local Siemens Healthineers technical support representative.", "distribution_pattern": "Worldwide distribution - US Nationwide distribution and the countries of Albania, Algeria, Angola, Argentina, Australia, \nAustria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, \nBenin, Bosnia Herzeg., Botswana, Brazil, Bulgaria, Burkina, Faso, Cambodia, Canada, Chile, Colombia, Croatia, Cura¿ao\nCyprus, Czech Republic, Denmark, Ecuador, Egypt, Finland, \nFrance, Fren.Polynesia, Georgia, Germany, Greece, Guadeloupe, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, \nIreland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kuwait, \nLebanon, Lithuania, Luxembourg, Macedonia, Malaysia, Mali\nMalta, Martinique, Mexico, Namibia, Netherlands, Norway, \nOman, P.R. China, Pakistan, Peru, Philippines, Poland, Portugal, Qatar, Rep. of Yemen, Republic Korea, Romania, \nRussian Fed., San Marino, Saudi Arabia, Senegal, Serbia, \nSingapore, Slovakia, Slovenia, South Africa, Spain, Sweden, \nSwitzerland, Syria, Taiwan, Thailand, Trinidad,Tobago, Turkey, Turkmenistan, U.A.E., Ukraine, United Kingdom, Uruguay, \nVatikancity, Vietnam.", "openfda": { "k_number": [ "K222148", "K945212", "K945678", "K955673", "K920544", "K151133", "K081890", "K962305", "K936023", "K953116", "K032524", "K950625", "K040725", "K040073", "K932531", "K890491", "K052905", "K941171", "K980858", "K970326", "K992444", "K992849", "K900276", "K852371", "K061150", "K022528", "K950342", "K963963", "K162414", "K211840", "K961278", "K930148", "K050758", "K874427", "K900802", "K960072", "K042173", "K040026", "K901186", "K240252", "K172604", "K901189", "K071562", "K972354", "K943894", "K024002", "K925274", "K944126", "K823355", "K900078", "K880507", "K932532", "K250943", "K060423", "K951459", 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