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.

Recall Insight

This FDA Devices action (record #Z-2274-2025) was formally reported on August 13, 2025, with the manufacturer initiating the action on June 25, 2025. It is classified under Moderate severity (Class II), with a current status of Ongoing. Nuclein LLC is listed as the recalling firm, operating out of Austin, TX. Federal records indicate 710 units units are affected.

The documented reason for this recall is: Due to manufacturing error, assay test may result in missed diagnosis or delay of treatment. (Potential false negative result) Distribution data in the federal record shows the product reached: US distribution to: Florida, New York, Texas, and West Virginia. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 1 year old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.