Recall Z-2861-2026 · NSU Instrumentation For Clinical Multiplex Test Systems
Nuclein LLC
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 cartridg
| Date | Aug 3, 2026 (initiated Jun 25, 2025) |
| Status | Open, Classified |
| Reason | Due to a software issue which may result in false co-infection (e.g., Positive for Flu A, when SARS-CoV-2 is present). |
| Root cause | Process control |
| Action | 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 |
| Quantity | 2 |
| Distribution | US Nationwide distribution in the state of Texas. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K241652 | DASH® SARS-CoV-2 & Flu A/B Test Nuclein, LLC, Dec 20, 2024 |