FDAFDA · Food and drugs·Recall number Z-3164-2026
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.
Published September 23, 2026 · Recall initiated: October 22, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Due to a software issue
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Nuclein LLC
- Distributor
- 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.
- Lot
- 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 C03250005 (01)00850063063005(11)250408(21)C03250005 C03250006 (01)00850063063005(11)250319(21)C03250006 C03250007 (01)00850063063005(11)250319(21)C03250007 C03250008 (01)00850063063005(11)250512(21)C03250008 C03250009 (01)00850063063005(11)250415(21)C03250009 C03250012 (01)00850063063005(11)250417(21)C03250012 C03250013 (01)00850063063005(11)250408(21)C03250013 C03250015 (01)00850063063005(11)250421(21)C03250015 C03250016 (01)00850063063005(11)250417(21)C03250016 C03250018 (01)00850063063005(11)250421(21)C03250018 C03250019 (01)00850063063005(11)250421(21)C03250019 C03250020 (01)00850063063005(11)250423(21)C03250020 C04250003 (01)00850063063005(11)250509(21)C04250003 C04250004 (01)00850063063005(11)250421(21)C04250004 C04250005 (01)00850063063005(11)250509(21)C04250005 C05250006 (01)00850063063005(11)250512(21)C05250006 C05250007 (01)00850063063005(11)250513(21)C05250007 C05250008 (01)00850063063005(11)250513(21)C05250008 C05250010 (01)00850063063005(11)250512(21)C05250010 C05250011 (01)00850063063005(11)250514(21)C05250011 C05250012 (01)00850063063005(11)250514(21)C05250012 C05250013 (01)00850063063005(11)250514(21)C05250013 C05250016 (01)00850063063005(11)250520(21)C05250016 C05250017 (01)00850063063005(11)250520(21)C05250017 C05250021 (01)00850063063005(11)250521(21)C05250021 C05250022 (01)00850063063005(11)250520(21)C05250022 C05250024 (01)00850063063005(11)250520(21)C05250024 C05250026 (01)00850063063005(11)250605(21)C05250026 C05250028 (01)00850063063005(11)250509(21)C04250028 C05250029 (01)00850063063005(11)250605(21)C05250029 C05250030 (01)00850063063005(11)250606(21)C05250030 C05250031 (01)00850063063005(11)250605(21)C05250031 C05250033 (01)00850063063005(11)250609(21)C05250033 C05250034 (01)00850063063005(11)250609(21)C05250034 C05250035 (01)00850063063005(11)250609(21)C05250035 C05250036 (01)00850063063005(11)250609(21)C05250036 C05250039 (01)00850063063005(11)250606(21)C05250039 C05250040 (01)00850063063005(11)250609(21)C05250040 C05250042 (01)00850063063005(11)250610(21)C05250042 C06250001 (01)00850063063005(11)250610(21)C06250001 C06250002 (01)00850063063005(11)250610(21)C06250002 C06250003 (01)00850063063005(11)250610(21)C06250003 C06250005 (01)00850063063005(11)250611(21)C06250005 C06250006 (01)00850063063005(11)250611(21)C06250006 C06250008 (01)00850063063005(11)250611(21)C06250008 C06250010 (01)00850063063005(11)250611(21)C06250010 C06250012 (01)00850063063005(11)250624(21)C06250012 C0625001
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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