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Data refreshed September 30, 2026 · last 180 days

502recalls · last 30 days
50CPSC · last 30 days
387FDA · last 30 days
60NHTSA · last 30 days
5FSIS · last 30 days
3,487in 180-day window

Nuclein LLC recalls

RecallSweep is tracking 2 recall notices naming Nuclein LLC in the last 180 days, issued by FDA. The most recent is dated September 23, 2026 and the oldest in this window August 12, 2026. They cover Medical Devices.

This page lists what the issuing agencies published. It is not a statement about Nuclein LLC beyond those notices — open each official notice for the authoritative detail.

Recall notices naming Nuclein LLC

2 recalls.

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,…

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

Look up recall #Z-3164-2026 in the FDA enforcement database ↗ Permalink →
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 Product Descri…

Affected quantity: 2

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

Look up recall #Z-2861-2026 in the FDA enforcement database ↗ Permalink →

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