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 Descri…
Hazard
Due to a software issue which may result in false co-infection (e.g., Positive for Flu A, when SARS-CoV-2 is present).
Details
Distribution: US Nationwide distribution in the state of Texas.. Recall #Z-2861-2026, initiated 20250625. Voluntary: Firm initiated.
Products affected
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) ins…
Recall status
Ongoing
Reference: FDA Z-2861-2026 · Issued August 12, 2026 · Class II · Indexed by RecallSweep from the official FDA feed.