Brand Name: DASH Rapid PCR Instrument Product Name: DASH Rapid PCR Instrument Model/Catalog Number: SG-0002 Software Ver
FDA device recall Z-2861-2026 · posted 2026-08-03 · Open, Classified
Recall details
- Recalling firm
- Nuclein LLC
- 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).
- Action taken
- On 06/25/2025, a "MEDICAL DEVICE RECALL" Letter was emailed to customers informing them that, Nuclein identified an incorrect software file on a small number of DASH instruments that creates a possibility for the affected instruments to make incorrect calls that indicate coinfection in the patient tested. On 07/16/2026, the firm emailed an updated "URGENT: MEDICAL DEVICE RECALL" Letter. -Customer were informed regarding updates to the reason for the recall and potential health risks. -Customer were instructed to: All affected DASH Instrument identified in Section 6 (below) have already been replaced. Please complete the Acknowledgement and Receipt Form below and either email the completed form to customersupport@nuclein.com or mail to the address provided at the bottom of the Acknowledgement and Receipt Form. For Questions - contact Nuclein at Phone: (888) 992-DASH on Monday through Friday, 8:30 AM to 5:30 PM, CST. Email: customersupport@nuclein.com Website: https://www.Nuclein.com/contact-us/
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- NSU
- Quantity affected
- 2
- Distribution
- US Nationwide distribution in the state of Texas.
- Date initiated
- 2025-06-25
- Date posted
- 2026-08-03
- Location
- Austin, TX
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DASH® SARS-CoV-2 & Flu A/B Test (K241652) | Nuclein, LLC | 2024-12-20 |