Nuclein LLC Brand Name: Dash Rapid PCR Instrument Product Name: Dash Rapid PCR recall: Due to a software issue
Due to a software issue
The hazard: Device malfunction
This is a device recall, and in FDA language that usually means a correction rather than a removal: the device stays in use and the manufacturer fixes, patches or re-instructs.
What the notice says: Due to a software issue
Why it matters: The device may not perform as intended — a mechanical failure, a software defect, an inaccurate reading, or an alarm that does not sound. For a device someone depends on, the consequence of the failure is usually worse than the failure itself.
Symptoms and when to call a doctor
If the device supports a vital function, do not disable or remove it on your own judgement. Contact the clinician who prescribed or fitted it, and use the back-up arrangement they gave you. Go to an emergency department if the symptoms the device is meant to manage are getting worse, or if an implanted device gives an unexpected alarm or shock.
This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.
Recall details
- Recall number
- Z-3164-2026
- Published
- September 23, 2026
- Risk level
- Class II
- Status
- Ongoing
- Issued by
- U.S. Food and Drug Administration
- Brand
- Nuclein LLC
- Product type
- Medical devices
- Units affected
- 182
- Distribution
- Nationwide
- Made in
- United States
- Lot / code info
- 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 C06250013 (01)00850063063005(11)250623(21)C06250013 C0625001…
- UPC codes
- 00850063063005
Products covered by this recall
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.
Check your product
The notice names 2 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.
UPC / barcode
Read the twelve digits under the barcode on the package.
- 00850063063005
Model or item number
On the rating label, the box or the instruction sheet.
- SG-0002 Software Version
Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.
What to do about Malfunction
Nuclein LLC — This is a device recall, and in FDA language that usually means a correction rather than a removal: the device stays in use and the manufacturer fixes, patches or re-instructs.
- Match the model, catalogue, lot and serial numbers on your device against the identifiers listed on this page.
- If the device is implanted, or you depend on it daily, speak to your clinician before changing anything about how you use it.
- Check whether the remedy is a software update, and if so confirm afterwards in the device menu that the version actually changed.
- If you are a clinic or facility, quarantine affected stock and record the correction in your recall log.
Replacements, repairs and reimbursement
Device remedies run through the supply chain, so the route depends on who sold you the unit.
- Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.
- If the device was billed to insurance or Medicare, the replacement is usually billed the same way; you should not face a second deductible for a recall.
- Keep every piece of correspondence. If a recalled device caused harm, that paper trail is what a claim rests on.
- Consumer-purchased devices such as monitors and test kits are normally replaced free, with return shipping paid.
Company contact: Nuclein LLC — 8305 Cross Park Dr, Austin, TX, 78754-5154
The official notice
This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.
Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls
Questions people ask about this recall
Why was Nuclein LLC medical devices recalled?
Due to a software issue Due to a software issue
How do I know if I have the recalled product?
Match the codes printed on your package against the notice: UPC 00850063063005; model number SG-0002 Software Version. If the code on your package is not on that list, your unit is outside the recall.
What should I do with it right now?
Match the model, catalogue, lot and serial numbers on your device against the identifiers listed on this page.
Can I get my money back?
Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.
Where was the recalled product sold?
It was distributed nationwide.
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