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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Diagnostic Equipment

DASH SARS-CoV-2 & Flu A/B Tests Recalled for Potential False Negative Risk

Agency Publication Date: August 6, 2025
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Summary

Nuclein LLC has recalled approximately 710 units of the DASH SARS-CoV-2 & Flu A/B Test (Model SG-0006) because of a manufacturing error. This defect can lead to false negative results for COVID-19 or Influenza A/B, which might cause a missed diagnosis or a delay in proper medical treatment. These combination tests are individually pouched, sold in kits of 10, and are designed for use with the DASH diagnostic instrument.

Risk

A false negative result means the test may indicate a person is not infected with COVID-19 or the flu when they actually are. This can lead to the unintended spread of the virus to others and a failure to receive necessary healthcare.

What You Should Do

  1. This recall involves the DASH SARS-CoV-2 & Flu A/B Test (Model SG-0006) with lot codes BB02 and BB03 and an expiration date of February 20, 2026.
  2. Stop using the recalled diagnostic products immediately.
  3. Contact the manufacturer, Nuclein LLC, or your distributor to arrange for the return, replacement, or correction of the affected tests.
  4. For additional information, call the FDA at 1-888-463-6332.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: DASH SARS-CoV-2 & Flu A/B Test
Variants: Combination COVID-19 and Flu test, 10 tests per kit
Model / REF:
SG-0006
Lot Numbers:
BB02 (Exp 20 Feb. 2026)
BB03 (Exp 20 Feb. 2026)
UDI:
0100850063063036(17)260220(10)BB02
0100850063063036(17)260220(10)BB03

Used on the DASH instrument. Individually pouched and labeled.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97228
Status: Active
Manufacturer: Nuclein LLC
Sold By: Authorized medical distributors; Direct to clinical laboratories
Manufactured In: United States
Units Affected: 710 units
Distributed To: Florida, New York, Texas, West Virginia

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.