DASH COVID and flu tests may give a false negative result
DASH SARS-CoV-2 & Flu A/B Tests are being recalled because a manufacturing error means the assay may result in a missed diagnosis or delay of treatment through a potential false negative. 710 units affected.
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: Risk-of-harm product: the manufacturer states the test may return a false negative and delay treatment, with no patient harm reported.
Plain-English summary
The DASH SARS-CoV-2 & Flu A/B Test, a combination COVID-19 and influenza test, model/catalog number SG-0006, is being recalled. Each test is individually pouched and labelled and supplied in quantities of 10. The action covers 710 units, including lot BB02 expiring 20 February 2026.
The stated reason is that, due to a manufacturing error, the assay test may result in a missed diagnosis or delay of treatment, meaning a potential false negative result. The FDA classified the action as Class II. The source does not report any patient harm having occurred.
Distribution was to Florida, New York, Texas and West Virginia.
Users should identify affected stock using the catalog number, UDI and lot numbers above and follow the instructions issued by the manufacturer.
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
- Hazard
- false-negative
- manufacturing-error
- missed-diagnosis
- class-ii
Distribution
Distribution scope not specified by the agency.
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