Recall Z-2274-2025 · QOF Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents
Nuclein LLC
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.
| Date | Aug 6, 2025 (initiated Jun 25, 2025) |
| Status | Open, Classified |
| Reason | Due to manufacturing error, assay test may result in missed diagnosis or delay of treatment. (Potential false negative result) |
| Root cause | Process control |
| Action | On June 25, 2025, Nuclein, LLC issued a Urgent: Medical Device Recall notification to affected customers. On July 8, 2025 an updated notification was issued via E.Mail. a. Review your inventory of DASH SARS-CoV-2 & Flu A/B Tests to confirm the quantity of Lot BB02 or BB03 that you have remaining. b. Suspend the use and quarantine the affected lot of DASH SARS-CoV-2 & Flu A/B Tests; Nuclein will replace any unused affected product. c. Review all results of the product lots detailed in Section 6, below, to identify potentially erroneous diagnosis, except in those cases where alternative con |
| Quantity | 710 units |
| Distribution | US distribution to: Florida, New York, Texas, and West Virginia |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K241652 | DASH® SARS-CoV-2 & Flu A/B Test Nuclein, LLC, Dec 20, 2024 |