Nuclein Llc: Instrumentation For Clinical Multiplex Test Systems
Recall Summary Nuclein LLC is recalling DASH Rapid PCR Instruments (Model SG-0002, Software Version 6.0.2) used to test for infectious diseases like COVID-19 and flu. A software problem can cause the instrument to incorrectly report that a patient has multiple infections when they actually have only one—for example, showing a positive result for flu when only COVID-19 is present. The affected devices were distributed nationwide across all U.S. states and Washington, D.C.
- Recalling firm
- Nuclein LLC
- 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....
- 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).
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2025-06-25
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- US Nationwide distribution in the state of Texas.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/aa32fe7c-941e-49cc-ba78-dd912f9ab8b0