The Recall Desk
HighFDA (Devices)·Z-2274-2025·Announced 2025-08-13

DASH COVID-19 and Flu Test Recalled for Potential False Negatives

Nuclein LLC is recalling DASH SARS-CoV-2 & Flu A/B Test kits due to a manufacturing error that may produce false negative results, potentially delaying diagnosis and treatment.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall of a diagnostic test with potential to cause missed diagnosis and delayed treatment. No illnesses or injuries have been reported in the source material, and the hazard is described as potential rather than confirmed. Per the rubric, risk-of-harm products where injury has not yet been reported are scored as High (3).

Plain-English summary

Nuclein LLC is recalling DASH SARS-CoV-2 & Flu A/B Test kits (Model/Catalog Number SG-0006) due to a manufacturing error that may result in false negative results, potentially missing a COVID-19 or flu diagnosis and delaying treatment.

The recall affects 710 units distributed in Florida, New York, Texas, and West Virginia. The affected lots are BB02 and BB03, both expiring February 20, 2026.

Users of these test kits should discontinue use immediately. Those who have received results from these affected lots should contact their healthcare provider for guidance.

The recalled product

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.
Manufacturer
Nuclein LLC
Category
Medical Device — Diagnostic Test Kit
Hazard
  • false-negative-result
  • missed-diagnosis

Distribution

Distribution scope not specified by the agency.

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