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QIAstat-Dx® Respiratory Panel Plus
QIAGEN GmbH · Model V1 · UDI-DI 04053228039402
QOF
Prescription
10
510(k) clearances
48
Adverse events
9
Recalls
31
Facilities
Description
IVD kit containing 6 tests
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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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.