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FilmArray® Gastrointestinal (GI) Panel
BIOFIRE DIAGNOSTICS, LLC · Model RFIT-ASY-0116 · UDI-DI 00815381020109
PCH
Prescription
5
510(k) clearances
257
Adverse events (2 deaths)
24
Recalls
16
Facilities
Description
IVD reagent kit containing 30 tests.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-11-03 | GET TESTED INTERNATIONAL AB | Distribution without premarket approval/clearance. |
| 2025-11-03 | GET TESTED INTERNATIONAL AB | Distribution without premarket approval/clearance. |
| 2025-11-03 | GET TESTED INTERNATIONAL AB | Distribution without premarket approval/clearance. |
| 2025-11-03 | GET TESTED INTERNATIONAL AB | Distribution without premarket approval/clearance. |
| 2025-11-03 | GET TESTED INTERNATIONAL AB | Distribution without premarket approval/clearance. |
| 2024-05-16 | BioFire Diagnostics, LLC | Due to increase of false positive Vibrio/Vibrio Cholerae results when using a certain transport medium. |
| 2024-01-26 | BioFire Diagnostics, LLC | Due to potential signals of increased false positive Norovirus results when using the gastrointestinal (GI) panel. |
| 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 |
| 2023-06-05 | Luminex Corporation | It is possible that in rare instances the VERIGENE CDF Nucleic Acid Test Kit (Part No. 20-005-022) and the VERIGENE Enteric Pathogens Nucleic Acid Test Kit (Part No. 20-005-023) co |
| 2023-04-25 | BioFire Diagnostics, LLC | The firm has identified an increased risk of obtaining false positive Cryptosporidium results from customers using the BIOFIRE FILMARRAY Gastrointestinal (GI) Panel |
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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.