Nuclein LLC: Brand Name: DASH Rapid PCR Instrument Product Name: DASH Rapid PCR Instrument Model/Catalog Number: SG-0002 Software Version: 6.0.2 Prod
Read the official notice at FDA (device) →
The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- Nuclein LLC
- Product
- 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.
- Reason / hazard
- Due to a software issue which may result in false co-infection (e.g., Positive for Flu A, when SARS-CoV-2 is present).
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- US Nationwide distribution in the state of Texas.
- Recall initiated
- 2025-06-25
- 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
- Product quantity
- 2
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Austin
- State
- TX
- Country
- United States
- Event id
- 99360
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