Recall Register

Food, drugs, devices › Firms

Nuclein LLC

FDA recalling firm · 3 enforcement events · 3 product records · 2025–2025 · TX

Nuclein LLC has 3 FDA enforcement events on this register (3 product records) between 2025 and 2025: 3 device; the busiest year was 2025 with 3.

0% of its events are Class I; the most common class is Class II (3). 3 events are listed as ongoing; the recalling firm's address is in TX.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

InitiatedProduct (first record)TypeClassRecordsStatus
22 Oct 2025Brand 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 reaction (RT-PCR)…DeviceClass II1Ongoing
25 Jun 2025DASH SARS-CoV-2 & Flu A/B Test Model/Catalog Number: SG-0006 combination COVID-19 and Flu test. Each DASH SARS-CoV-2 & Flu A/B Test is individually pouched and labeled. The tests are provided to users in quantities of 10 per kit. Used on the DASH instrument.DeviceClass II1Ongoing
25 Jun 2025Brand 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…DeviceClass II1Ongoing

By type and class

Device3
Class II3

Class I: 0% of this firm's events; 18% of all events on the register.

Events by year

25
26
Enforcement events for Nuclein LLC by year initiated.

Questions and answers

How many FDA recalls has Nuclein LLC had?

3 enforcement events (3 product records) on this register, 2025–2025: 3 device.

Are any Nuclein LLC recalls ongoing?

3 events are listed as ongoing in the current openFDA export.

What class are Nuclein LLC recalls?

3 Class II. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.