Home › Device types › PEN
Gram-Negative Bacteria And Associated Resistance Markers
FDA product code PEN · Class 2 · Microbiology
18
Registered devices
59
Adverse events
20
Recalls
11
510(k) clearances
Devices with this code
ePlex — GENMARK DIAGNOSTICS, INC.iC-GN Assay — ICUBATE, INCePlex — GENMARK DIAGNOSTICS, INC.ePlex — GENMARK DIAGNOSTICS, INC.Gram-Negative Blood Culture (BC-GN) Nucleic Acid Test Cartridge — NANOSPHERE, INC.FilmArray® BCID Panel — BIOFIRE DIAGNOSTICS, LLCePlex — GENMARK DIAGNOSTICS, INC.Gram-Negative Blood Culture (BC-GN) Utility Tray — NANOSPHERE, INC.BioFire® Blood Culture Identification 2 (BCID2) Panel — BIOFIRE DIAGNOSTICS, LLCePlex — GENMARK DIAGNOSTICS, INC.BioFire® Blood Culture Identification 2 (BCID2) Panel — BIOFIRE DIAGNOSTICS, LLCGram-Negative Blood Culture (BC-GN) Utility Tray — LUMINEX CORPORATIONePlex — GENMARK DIAGNOSTICS, INC.Gram-Negative Blood Culture (BC-GN) Extraction Tray — LUMINEX CORPORATIONGram-Negative Blood Culture (BC-GN) Nucleic Acid Test Cartridge — LUMINEX CORPORATIONGram-Negative Blood Culture (BC-GN) Extraction Tray — NANOSPHERE, INC.FilmArray® BCID Panel — BIOFIRE DIAGNOSTICS, LLCLIAISON PLEX Gram-Negative Blood Culture Assay — LUMINEX CORPORATION
Recent 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 oc |
| 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/instrume |
| 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 |
| 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 |
| 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 FilmAr |
| 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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