DASH® SARS-CoV-2 & Flu A/B Test Kit
Nuclein, LLC · Model SG-0006 · UDI-DI 00850063063036
Description
The DASH SARS-CoV-2 & Flu A/B Test is a rapid reverse transcription polymerase chain reaction (RT-PCR) assay performed on the DASH Rapid PCR Instrument and is intended for the simultaneous in vitro qualitative detection and differentiation of SARS-CoV-2, influenza A and influenza B virus ribonucleic acid (RNA) in anterior nasal swab specimens from patients with signs and symptoms of respiratory tract infection. The test is intended to aid in the differential diagnosis of SARS-CoV-2, influenza A, and influenza B in humans in conjunction with other clinical, epidemiologic and laboratory findings. Positive results of a specific target are indicative of the presence of that viral RNA and may not be the definite cause of disease. Positive results do not rule out co-infection with other pathogens. Negative results do not preclude SARS-CoV-2, influenza A or influenza B infection and should not be used as the sole basis for patient management decisions.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-06-24 | BioFire Diagnostics, LLC | Due to increase in false negative results |
| 2026-04-01 | BioFire Diagnostics, LLC | Respiratory/sore throat panel test may result in false negative results and control failures. |
| 2025-10-22 | BioFire Diagnostics, LLC | Due to unintended movement of pouch chemistry, nucleic acid test may result in elevated risk of false negative results and risk of control failures. |
| 2025-06-25 | Nuclein LLC | Due to manufacturing error, assay test may result in missed diagnosis or delay of treatment. (Potential false negative result) |
| 2025-03-12 | Qiagen Sciences LLC | Identified faulty cartridges. If such a faulty cartridge is used for sample testing, false test results could occur. |
| 2024-11-08 | Hologic, Inc. | SARS-CoV-2/Flu A/B/RSV Assay Kit may erroneously produce SARS-CoV-2 false positive results. |
| 2023-11-27 | BioFire Diagnostics, LLC | A manufacturing event may contribute to elevated rates of false negative results while using gastrointestinal panel and respiratory panel, which could lead to inappropriate antibio |
| 2023-05-08 | BioFire Diagnostics, LLC | Due to manufacturing issue, panels may result in false negative results. |
| 2023-02-01 | BioFire Diagnostics, LLC | Due to temperature excursions with products (products being stored outside of the required temperature specifications) that may cause a reduction in performance. The temperature e |
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