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Gram-Negative Blood Culture (BC-GN) Extraction Tray

NANOSPHERE, INC. · Model 20-009-021 · UDI-DI 00857573006249

PEN Prescription

510(k) clearances

Adverse events (12 deaths)

Recalls

Facilities

Description

The Verigene® Gram-Negative Blood Culture Nucleic Acid Test (BC-GN) performed using the sample-to-result Verigene® System, is a qualitative multiplexed in vitro diagnostic test for the simultaneous detection and identification of selected gram-negative bacteria and resistance markers.

Recalls

Date	Firm	Reason
2025-04-16	Luminex Corporation	It was determined that the consumable issue may result in No Call - INT CTL 1 and/or False Negative results on a small portion of the lot of test cartridges.
2024-06-19	BioFire Diagnostics, LLC	If blood culture identification panel is used in conjunction with specific lots of culture media bottles, then false positive Serratia marcescens results may occur, due to an incre
2024-01-26	BioFire Diagnostics, LLC	Due to a trend in false positive Candida tropicalis results on blood culture panel when using certain BD BACTEC vial mediums
2023-10-17	BioFire Diagnostics, LLC	Routine quality control testing of affected blood culture identification panel with affected control panel may need to be amended, due to control panel/instrument characteristic ch
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
2021-10-11	BioFire Diagnostics, LLC	Due to an increased risk of false positive Acinetobacter calcoaceticus- baumannii complex results. The cause may be as a due to non-viable contamination in the blood culture vials
2021-07-20	BioFire Diagnostics, LLC	Due to product complaints received for false negative results (dropouts) with blood culture identification panel potential caused by a pouch manufacturing error.
2021-05-10	BioFire Diagnostics, LLC	Elevated rates of false negative results may occur when using blood culture panels due to issues in the manufacturing process. Pouches contained OPP from FilmArray Blood Culture Id
2021-01-26	BioFire Diagnostics, LLC	The firm has identified an increased risk of false positive Pseudomonas aeruginosa when BCID/BCID2 Panels are used with specific BD BACTEC" blood culture vials.
2021-01-26	BioFire Diagnostics, LLC	The firm has identified an increased risk of false positive Pseudomonas aeruginosa when BCID/BCID2 Panels are used with specific BD BACTEC" blood culture vials.

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Data 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.