{ "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": "2026-09-20", "results": { "skip": 0, "limit": 1, "total": 2 } }, "results": [ { "cfres_id": "198173", "product_res_number": "Z-1209-2023", "event_date_initiated": "2023-01-30", "event_date_posted": "2023-03-03", "recall_status": "Open, Classified", "res_event_number": "91504", "product_code": "QJR", "product_description": "Simplexa COVID-19 Direct, REF: MOL4150; including Reaction Mix, REF: MOL4150; with previous assay definition v2", "code_info": "UDI-DI: 20816101027020. Product REF/Lot/Reaction Mix REF/Lot:\nMOL4150/US13950/MOL4151/US14091,\nMOL4150/US14913/MOL4151/US14063,\nMOL4150/US13952/MOL4151/US14065,\nMOL4150/US13955/MOL4151/US14086,\nMOL4150/US13959/MOL4151/US14088,\nMOL4150/US13956/MOL4151/US14087,\nMOL4150/US13960/MOL4151/US14093,\nMOL4150/US13961/MOL4151/US14094,\nMOL4150/US13973/MOL4151/US13732,\nMOL4150/US13974/MOL4151/US13736,\nMOL4150/US14006/MOL4151/US13738,\nMOL4150/US14004/MOL4151/US15064,\nMOL4150/US14005/MOL4151/US13737,\nMOL4150/US14008/MOL4151/US14100,\nMOL4150/US14007/MOL4151/US14099,\nMOL4150/US14010/MOL4151/US14102,\nMOL4150/US14011/MOL4151/US14103,\nMOL4150/US14012/MOL4151/US15290,\nMOL4150/US14018/MOL4151/US14111,\nMOL4150/US14009/MOL4151/US14101,\nMOL4150/US14017/MOL4151/US14109,\nMOL4150/15061N/MOL4151/13474N,\nMOL4150/X15475N/MOL4151/X15479N,\nMOL4150/13330N/MOL4151/14829N,\nMOL4150/13331N/MOL4151/13751N,\nMOL4150/13336N/MOL4151/13752N,\nMOL4150/13968N/MOL4151/14036N,\nMOL4150/14346N/MOL4151/14038N,\nMOL4150/13967N/MOL4151/15082N", "firm_fei_number": "2023365", "recalling_firm": "DiaSorin Molecular LLC", "address_1": "11331 Valley View St", "city": "Cypress", "state": "CA", "postal_code": "90630-5366", "additional_info_contact": "714-220-1900", "reason_for_recall": "Direct amplification Discs , used with COVID-19 and Flu A/B & RSV assays, may leak and cause contamination, cross-contamination, invalid results, and error codes.", "root_cause_description": "Device Design", "action": "On 01/30/2023, correction notices were distributed to customers via in-person site visits. \nCustomers were asked to do the following:\n1) Discontinue use of affected devices using affected assay definitions.\n2) Customers can contact the recalling firm to replace affected kits. The firm can also provide assistance with inventory reconciliation/destruction, and if needed, assistance with potential instrument/lab decontamination.\n3) Any sample result with an error code (EC510, EC515, RNA IC, Insufficient Specimen Volume) should be retested following the Instructions for Use.\n4) If leakage is suspected, the spillage should be removed and the instrument surface should be decontaminated. Ensure the practice of Good Laboratory Procedures including regular cleaning.\n5) This recall notice should be shared with anyone who needs to be aware within your organization or shared with any organization where the potentially affected products have been transferred. Notify others within your network that may have remaining inventory of those kits.\n5) Complete and return the acknowledgement and receipt form and return to the recalling firm's Technical Service department at technicalinfo.molecular@diasorin.com\n\nProduct in the field with the previous high spin assay definitions are being recalled and replaced with current products with the current reduced spin assay definitions.\n\nCustomers with questions are encouraged to email (see above) or call Technical Service at (800) 838-4548, option 3, Monday - Friday, 7:00am to 5:00pm (Pacific Time)", "product_quantity": "90142", "distribution_pattern": "US Nationwide distribution including in the states of NJ, ME, ND, IL, MI, FL, GA, AZ, MA, CA, MO, SD, MN, PA, OH, VT, NE, WI, CO, DC, VA, TX, NH, IN, IA, MD, NC, AL, NY, KY, WV, RI, KS, NM, OK, WA, SC, CT, TN, NV, LA.", "openfda": { "registration_number": [ "3013019728", "3005248192", "3012758946", "3003335080", "3024756665", "3009014878", "3038610665", "3032562", "3016619649", "3014553740", "3004013603", "2243471", "2032682", "3010607747", "3016994837", "3003902721", "3019837962", "3004530258", "3010749841", "2023365", "3014214006", "3008517993", "3016608638", "3008632402", "1221359", "3017485950", "3013160357", "3009976420", "3009875001", "3004141078", "3017358793", "3016838963", "3025663244", "3011104381", "9615778", "3009207631", "3003795116", "3002792284", "9610126", "3004146366", "3003517954", "3009238284", "3012918440", "3017638293", "2031468", "1119779", "1528450", "3007420875", "2024800", "3009613136", "3010770794", "3024647994", "1524213", "1063851", "3013540184" ], "fei_number": [ "3013019728", "3005248192", "3012758946", "3003335080", "3024756665", "3009014878", "3038610665", "3016619649", "3014553740", "3004013603", "2243471", "3010607747", "3016994837", "3003902721", "3019837962", "3004530258", "1000351505", "3010749841", "2023365", "3014214006", "3008517993", "3016608638", "3008632402", "1221359", "1000122536", "3017485950", "3013160357", "3009976420", "3003952975", "3009875001", "3004141078", "3017358793", "3016838963", "3025663244", "1000442352", "3002023342", "3011104381", "3009207631", "3003795116", "3002792284", "3004146366", "3003517954", "3009238284", "3012918440", "3017638293", "3002806559", "1119779", "3007420875", "3002606748", "2024800", "3009613136", "3010770794", "3024647994", "1524213", "3013540184" ], "device_name": "Reagents, 2019-Novel Coronavirus Nucleic Acid", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "N" } } ] }