FDA Class II Medical Devices

Nuclein LLC: 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,…

Nuclein LLC · Affected quantity: 182

Hazard
Due to a software issue

Details
Distribution: US Nationwide distribution in the states of Alabama, Delaware, Florida, Georgia, Kansas, Massachusetts, , Maryland, Maine, Michigan, North Carolina, New York, Ohio, South Carolina, Tennessee, Texas, Virginia, Vermont.. Recall #Z-3164-2026, initiated 20251022. 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, 6.0.4, 6.0.5, 6.0.6 Product Description: The DASH¿ Rapid PCR Instrument (DASH Instrument) is an automated, fluorescence-based, reverse-transcription polymerase chain…

Recall status
Ongoing

Reference: FDA Z-3164-2026 · Issued September 23, 2026 · Class II · Indexed by RecallSweep from the official FDA feed.

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