fda
3 records
FDA Device Recall: FilmArray NGDS Warrior Panel NGDS-ASY-0007 is a qualitative, multiplexed, nuclei
2025-10-01
Class II — FilmArray NGDS Warrior Panel (NGDS-ASY-0007) has an increased risk of internal control failures when testing positive blood culture, which may lead to delayed results and additional diagnos...
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FDA Device Recall: FilmArray NGDS Warrior Panel, Ref: NGDS-ASY-0007, UDI: (01)00851458005136, IVD,
2020-03-11
Class III — The firm has identified that an incorrect instruction for use (IFU) revision was included in the qualitative, multiplexed, nucleic acid-based in vitro diagnostic test kit.
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FDA Device Recall: JBAIDS Instrument System Software version 3.5.0.72. The JBAIDS instrument is
2014-09-24
Class III — BioFire Defense, LLC is initiating a field action for JBAIDS Software version 3.5.0.72 because the wrong version software may have been installed.
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ny_corps
1 records
NY Corp: BIOFIRE DEFENSE, LLC
2025-02-28
FOREIGN LIMITED LIABILITY COMPANY | County: New York | Jurisdiction: Delaware
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