DASH Rapid PCR Instrument Product Name recall
Nuclein LLC recalled DASH Rapid PCR Instrument Product Name on August 12, 2026 because of due to a software issue which may result in false co-infection (e.g., Positive for Flu A, when SARS-CoV-2 is present). It was sold nationwide.
Why it was recalled
Due to a software issue which may result in false co-infection (e.g., Positive for Flu A, when SARS-CoV-2 is present).
What's recalled
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. Compo…
Quantity: 2
What to do
Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.
Read the official FDA noticeDetails
- Company
- Nuclein LLC, Austin, TX
- Date
- Severity
- Class II
the product could cause temporary or reversible health problems. - Where sold
- Nationwide
US Nationwide distribution in the state of Texas. - Status
- Ongoing
- Recall number
- Z-2861-2026
- Source
- U.S. Food and Drug Administration
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