FDAFDA recall Z-2861-2026 · Aug 12, 2026
Nuclein LLC: Brand Name: DASH Rapid PCR Instrument Product Name: DASH Rapid PCR Instrument Model/Catalo recall
Recall found
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 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).
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- 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
- Distribution
- US Nationwide distribution in the state of Texas.
- Recalling firm
- Nuclein LLC, Austin, TX
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2025-06-25
Source: openFDA enforcement record Z-2861-2026 · search recall number Z-2861-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.