FDA Medical devices recall ·
DASH Rapid PCR Instrument Product Name: DASH Rapid PCR Instrument Model recall
- Recall number
- Z-3164-2026
- Date
- (initiated October 22, 2025)
- Company / brand
- Nuclein LLC
8305 Cross Park Dr, Austin, TX, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 182
- Hazard tags
- Software
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Brand Name: DASH Rapid PCR Instrument Product Name: DASH Rapid PCR Instrument Model/Catalog Number: SG-0002 Software Version: 6.0.2, 6.0.4, 6.0.5, 6.0.6 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.
Why was it recalled?
Due to a software issue
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Instrument Serial Numbers / UDI codes: C01250001 (01)00850063063005(11)250217(21)C01250001 C01250003 (01)00850063063005(11)250217(21)C01250003 C01250004 (01)00850063063005(11)250214(21)C01250004 C01250005 (01)00850063063005(11)250214(21)C01250005 C01250006 (01)00850063063005(11)250218(21)C01250006 C01250007 (01)00850063063005(11)250218(21)C01250007 C01250008 (01)00850063063005(11)250218(21)C01250008 C01250009 (01)00850063063005(11)250218(21)C01250009 C01250010 (01)00850063063005(11)250218(21)C01250010 C02250002 (01)00850063063005(11)250221(21)C02250002 C02250003 (01)00850063063005(11)250221(21)C02250003 C02250004 (01)00850063063005(11)250221(21)C02250004 C02250005 (01)00850063063005(11)250221(21)C02250005 C02250007 (01)00850063063005(11)250225(21)C02250007 C02250008 (01)00850063063005(11)250307(21)C02250008 C02250009 (01)00850063063005(11)250225(21)C02250009 C02250010 (01)00850063063005(11)250225(21)C02250010 C02250011 (01)00850063063005(11)250227(21)C02250011 C02250012 (01)00850063063005(11)250227(21)C02250012 C02250014 (01)00850063063005(11)250227(21)C02250014 C02250015 (01)00850063063005(11)250227(21)C02250015 C02250016 (01)00850063063005(11)250307(21)C02250016 C02250018 (01)00850063063005(11)250310(21)C02250018 C02250019 (01)00850063063005(11)250311(21)C02250019 C02250020 (01)00850063063005(11)250311(21)C02250020 C03250002 (01)00850063063005(11)250627(21)C03250002 C03250003 (01)00850063063005(11)250403(21)C03250003 C03250004 (01)00850063063005(11)250404(21)C03250004 C0325
Distribution
US Nationwide distribution in the states of Alabama, Delaware, Florida, Georgia, Kansas, Massachusetts, , Maryland, Maine, Michigan, North Carolina, New York, Ohio, South Carolina, Tennessee, Texas, Virginia, Vermont.
States: Alabama Delaware Florida Georgia Kansas Massachusetts Maryland Maine Michigan North Carolina New York Ohio South Carolina Tennessee Texas Virginia Vermont
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-3164-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.