Brand Name: DASH Rapid PCR Instrument Product Name: DASH Rapid PCR Instrument
Medical device recall Z-3164-2026. Published in FDA’s Enforcement Report on Sep 23, 2026.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Sep 23, 2026. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word, and 17 states named
- 182 how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Due to a software issue
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are 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.
182, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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…
Every code shown here, 1,973 characters
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…
FDA’s list runs to 9,502 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
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 states and territories these words name
17 states and territories.
Every one of them
- Alabama
- Delaware
- Florida
- Georgia
- Kansas
- Massachusetts
- Maryland
- Maine
- Michigan
- North Carolina
- New York
- Ohio
- South Carolina
- Tennessee
- Texas
- Virginia
- Vermont
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Oct 22, 2025.
- FDA classified it on Sep 14, 2026.
- FDA’s Enforcement Report published it on Sep 23, 2026.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Nuclein LLC, of Austin, TX.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: E-Mail.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 9,502 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.