United StatesThe DASH Rapid PCR Instrument (Brand: DASH; model/catalog SG-0002) running software versions 6.0.2, 6.0.4, 6.0.5, or 6.0.6 — 182 units with listed instrument serial numbers/UDI codes distributed across multiple U.S. states — is subject to an ongoing recall by Nuclein LLC. The recall was initiated because of a software issue.
What's being recalled
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.
Recalling firm: Nuclein LLC, Austin, TX, United States.
How to identify it
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…
The hazard
Due to a software issue
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
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.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)