{"recall":{"id":"fda-device-99360","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"Nuclein LLC recalls Brand Name: DASH Rapid PCR Instrument Product Name: DASH Rapid PCR Instrument Model/Catalog Number: SG-0002 So","firm":"Nuclein LLC","date":"2025-06-25","reported":"2026-08-12","status":"Ongoing","classification":"Class II","products":[{"name":"Brand Name: DASH Rapid PCR Instrument Product Name: DASH Rapid PCR Instrument Model/Catalog Number: SG-0002 Software Version: 6.0.2 Product Description: The DASH¿ Rapid PCR Instrument (DASH Instrument) is an automated, fluorescence-based, reverse-transcription polymerase chain reaction (RT-PCR) instrument that extracts specimens and performs nucleic acid amplified tests (NAAT) in DASH test cartridges for the qualitative detection of infectious diseases. The DASH Instrument is intended for use in conjunction with DASH Rapid PCR System tests to aid in the diagnosis of infectious diseases. Component: No.","code":"Lot Code: SN: C01250010; UDI: (01)00850063063005(11)250218(21)C01250010; SW: 6.0.2 SN: C02250006; UDI:(01)00850063063005(11)250225(21)C02250006; SW: 6.0.2","quantity":"2","number":"Z-2861-2026","classification":"Class II"}],"reason":"Due to a software issue which may result in false co-infection (e.g., Positive for Flu A, when SARS-CoV-2 is present).","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"US Nationwide distribution in the state of Texas.","nationwide":true,"states":[],"units":"2","remedy":"","whatToDo":"Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.","contact":"","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99360","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"e0dc8e9f1e29eb11","firstSeen":"2026-11-02T13:57:14.206Z","updatedAt":"2026-11-02T13:57:14.206Z","history":[]},"official":{"fetchedAt":"2026-11-02T13:57:14.206Z","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","officialUrl":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99360","record":[{"status":"Ongoing","city":"Austin","state":"TX","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99360","recalling_firm":"Nuclein LLC","address_1":"8305 Cross Park Dr","address_2":"","postal_code":"78754-5154","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"US Nationwide distribution in the state of Texas.","recall_number":"Z-2861-2026","product_description":"Brand Name: DASH Rapid PCR Instrument  Product Name: DASH Rapid PCR Instrument  Model/Catalog Number: SG-0002  Software Version: 6.0.2  Product Description: The DASH¿ Rapid PCR Instrument (DASH Instrument) is an automated, fluorescence-based, reverse-transcription polymerase chain reaction (RT-PCR) instrument that extracts specimens and performs nucleic acid amplified tests (NAAT) in DASH test cartridges for the qualitative detection of infectious diseases. The DASH Instrument is intended for use in conjunction with DASH Rapid PCR System tests to aid in the diagnosis of infectious diseases.  Component: No.","product_quantity":"2","reason_for_recall":"Due to a software issue which may result in false co-infection (e.g., Positive for Flu A, when SARS-CoV-2 is present).","recall_initiation_date":"20250625","center_classification_date":"20260803","report_date":"20260812","code_info":"Lot Code: SN: C01250010; UDI: (01)00850063063005(11)250218(21)C01250010; SW: 6.0.2 SN: C02250006; UDI:(01)00850063063005(11)250225(21)C02250006; SW: 6.0.2","more_code_info":""}]}}