Nuclein DASH Rapid PCR Instrument Recalled for Software Issue
Nuclein LLC is recalling 182 DASH Rapid PCR Instruments due to a software issue. The recall affects units distributed in 18 US states.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The FDA classified this as a Class II recall. Per the rubric, Class II recalls without specific reports of hospitalization or severe injury are typically scored as High (3), representing a risk of harm where injury has not yet been reported.
Plain-English summary
Nuclein LLC is recalling 182 units of the DASH Rapid PCR Instrument (Model SG-0002) due to a software issue. The affected instruments are automated, fluorescence-based, reverse-transcription polymerase chain reaction (RT-PCR) devices used for the qualitative detection of infectious diseases. The recall includes instruments running software versions 6.0.2, 6.0.4, 6.0.5, and 6.0.6.
The affected units were distributed nationwide in the United States, specifically in Alabama, Delaware, Florida, Georgia, Kansas, Massachusetts, Maryland, Maine, Michigan, North Carolina, New York, Ohio, South Carolina, Tennessee, Texas, Virginia, and Vermont. The source text does not specify the exact nature of the software defect or the potential impact on test results.
Healthcare facilities and users should stop using the affected DASH Rapid PCR Instruments and contact Nuclein LLC for further instructions on the recall. The FDA has classified this as a Class II recall, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Brand Name: DASH Rapid PCR Instrument Product Name: DASH Rapid PCR Instrument Model/Catalog Number: SG-0002 Software Version: 6.0.2, 6.0.4, 6.0.5, 6.0.6 Product Description: The DASH¿ Rapid PCR Instrument (DASH Instrument) is an automated, fluorescence-based…
- Manufacturer
- Nuclein LLC
- Hazard
- Affected units
- 182
Distribution
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