CLASS II ONGOING Device recall · Reported 12 Aug 2026 · FDA Enforcement Report
DASH Rapid PCR Instrument recalled by Nuclein
Nuclein is recalling DASH Rapid PCR Instrument, distributed nationwide in the US. The recall was initiated on 25 Jun 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2861-2026
- FDA event ID
- 99360
- Recalling firm
- Nuclein, Austin, TX
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 25 Jun 2025
- FDA classified
- 3 Aug 2026
- Reported
- 12 Aug 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Test Kits & Diagnostics
Timeline
| 25 Jun 2025 | Recall initiated by company | |
| 3 Aug 2026 | Classified by FDA | +404 days |
| 12 Aug 2026 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Due to a software issue which may result in false co-infection (e.g., Positive for Flu A, when SARS-CoV-2 is present).
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Brand Name: DASH Rapid PCR Instrument Product Name: DASH Rapid PCR Instrument Model/Catalog Number: SG-0002 Software Version: 6.0.2 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.
Where it was distributed
US Nationwide distribution in the state of Texas.
Questions about this recall
Is DASH Rapid PCR Instrument recalled?
Yes. Nuclein recalled DASH Rapid PCR Instrument on 25 Jun 2025. The recall is Class II and its status is Ongoing. Recall number Z-2861-2026.
Why was it recalled?
Due to a software issue which may result in false co-infection (e.g., Positive for Flu A, when SARS-CoV-2 is present).
Which lots are affected?
Lot Code: SN: C01250010; UDI: (01)00850063063005(11)250218(21)C01250010; SW: 6.0.2 SN: C02250006; UDI:(01)00850063063005(11)250225(21)C02250006; SW: 6.0.2
Where was it sold?
US Nationwide distribution in the state of Texas.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Nuclein
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Dash Sars-CoV-2 & Flu A/B Test recalled by Nuclein | Nuclein | Potency & Assay | 5 states |
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