Brand Name: DASH Rapid PCR Instrument Product Name: DASH Rapid PCR… — Class II medical device recall Z-2861-2026
Ongoing recall by Nuclein LLC, reported 2026-08-12, distributed nationwide. Due to a software issue which may result in false co-infection (e.g., Positive for Flu A, when SARS-CoV-2 is p
| Recall number | Z-2861-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Nuclein LLC, Austin, TX, United States |
| Recall initiated | 2025-06-25 |
| Classified | 2026-08-03 |
| Reported by FDA | 2026-08-12 |
| Distributed | Nationwide (US) |
| Quantity | 2 |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00850063063005 |
| Lot numbers | C01250010 |
| Model numbers | SG-0002 |
Product
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.
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).
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2861-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.