Recall Z-2274-2025— Nuclein LLC
Class II · Ongoing
Class II FDA medical device recall by Nuclein LLC, initiated 2025-06-25. It names one FDA 510(k) clearance: K241652. Product: DASH 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.. Reason: Due to manufacturing error, assay test may result in missed diagnosis or delay of treatment. (Potential false negative result).
- Recalling firm
- Nuclein LLC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-06-25
- Firm location
- Austin, TX, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
DASH 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.
Reason for recall
Due to manufacturing error, assay test may result in missed diagnosis or delay of treatment. (Potential false negative result)
Data sourced from openFDA. This site is unofficial and independent of the FDA.