{ "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": "210915", "product_res_number": "Z-0599-2025", "event_date_initiated": "2024-10-21", "event_date_posted": "2024-12-04", "recall_status": "Open, Classified", "res_event_number": "95666", "product_code": "JZG", "product_description": "Atellica CH 2-Microglobulin (B2M) - In vitro diagnostic use in the quantitative determination of 2-microglobulin in human serum and plasma.\nSiemens Material Number (SMN): 11097635", "code_info": "UDI-DI: 00630414595566\n\nAll in-date and future Atellica CH B2M reagent lots", "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 for falsely depressed auto-diluted\nresults for samples above the measuring interval of 18.00 mg/L, up to 30.00 mg/L, when using the Atellica CH 2-Microglobulin (B2M) reagent.", "root_cause_description": "Under Investigation by firm", "action": "Siemens issued Urgent Medical Device Correction (UMDC) ACHC25-02.A.US was issued to US affected customers by FedEx beginning on 10/28/2024 and Urgent Field Safety Notice (UFSN) ACHC25-02.A.OUS. Letter states reason for recall, health risk and action to take:\nPlease review this letter with your Medical Director to determine the appropriate\ncourse of action, including for any previously generated results, if applicable.\n\" Manually dilute patient samples that are > 18.00 mg/L:\n1. Navigate to the CH Test Definition screen.\n2. Under Measuring Interval, uncheck Repeat when Outside Measuring Interval. \n3. For samples that generate test results > 18.00 mg/L, prepare a 1:2 manual\ndilution with saline solution (0.9% unbuffered Isotonic saline).\n4. From the Create Patient Order screen, order the sample and enter 2 in the\nmanual dilution field on the left of the screen.\nNote: The system will apply the 1:2 dilution factor and calculate the final result.\n5. Process the manually diluted sample.\n\n\"Complete and return the Field Correction Effectiveness Check Form attached to this letter within 30 days.\n\"Please retain this letter with your laboratory records and forward this letter to those who may have received this product.\nResolution\nThe Atellica CH B2M assay IFU will be updated with the above steps to support manual 1:2 dilution only with saline for samples > 18.00 mg/L. Please see Appendix, Table 2, for data using these revised instructions.\n\nContact your Siemens Healthineers Customer Care Center or your local Siemens Healthineers technical support representative.", "product_quantity": "11330 units", "distribution_pattern": "Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Bahrain, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Greece, Hungary, India, Iran, Israel, Italy, Ivory Coast, Japan, Jordan, Kuwait, Mexico, Morocco, Oman, P.R. China, Pakistan, Paraguay, Poland, Portugal, Saudi Arabia, Saudi Arabia, Serbia, Slovakia, South Africa, Spain, Switzerland, Thailand, Turkey, U.A.E., Uganda, United Kingdom, Uruguay, Uzbekistan, Vietnam, Zaire.", "openfda": { "k_number": [ "K063272", "K946069", "K910052", "K890421", "K931702", "K943686", "K964791", "K083463", "K920132", "K864130", "K912173", "K946068", "K032692", "K940353", "K991136", "K983895", "K844469", "K900449", "K933648", "K980724", "K993711", "K911881", "K050613", "K944846", "K890694", "K914225", "K904254", "K901333", "K955596", "K903215", "K973813", "K122066", "K964767", "K903578", "K913131", "K915508", "K946070", "K912940", "K001022", "K083289", "K946048", "K840601", "K843967", "K920300", "K014270", "K110874", "K923421", "K880719", "K161297", "K895496", "K072078", "K002731", "K900440" ], "registration_number": [ "2432235", "9612316", "8031673", "2245285", "3022178699", "2050012", "3012471076", "9610099", "3005529799", "2084025", "9610806", "3003423869", "3006198300", "3013059683", "1036362", "3014607865", "9610126", "3002806944", "9680746", "3003741796", "3003871639", "1832216", "3021841051", "9610746", "9614373", "3009189893", "3017379203", "3005333358", "3002800697", "3005984081", "2050010", "3014325803", "3004493545", "9610529", "3003795116" ], "fei_number": [ "3002808328", "2432235", "2245285", "3002806559", "3022178699", "1000206808", "2050012", "3012471076", "3005529799", "2084025", "3003423869", "3006198300", "3013059683", "1036362", "3014607865", "3002806560", "3002806944", "3003741796", "3003871639", "3002808340", "3021841051", "1832216", "3002806778", "3009189893", "3017379203", "3001644026", "2967", "3005333358", "3002800697", "3005984081", "3014325803", "2050010", "3004493545", "3002806557", "3003795116" ], "device_name": "System, Test, Beta-2-Microglobulin Immunological", "medical_specialty_description": "Immunology", "regulation_number": "866.5630", "device_class": "2" } } ] }