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Gram-Positive Bacteria And Their Resistance Markers
FDA product code PAM · Class 2 · Microbiology
19
Registered devices
621
Adverse events
11
Recalls
7
510(k) clearances
Devices with this code
ePlex — GENMARK DIAGNOSTICS, INC.ePlex — GENMARK DIAGNOSTICS, INC.Gram-Positive Blood Culture (BC-GP) Utility Tray — LUMINEX CORPORATIONePlex — GENMARK DIAGNOSTICS, INC.FilmArray® BCID Panel — BIOFIRE DIAGNOSTICS, LLCePlex — GENMARK DIAGNOSTICS, INC.BioFire® Blood Culture Identification 2 (BCID2) Panel — BIOFIRE DIAGNOSTICS, LLCePlex — GENMARK DIAGNOSTICS, INC.BioFire® Blood Culture Identification 2 (BCID2) Panel — BIOFIRE DIAGNOSTICS, LLCGram-Positive Blood Culture (BC-GP) Nucleic Acid Test Cartridge — LUMINEX CORPORATIONiC-GPC Assay — ICUBATE, INCePlex — GENMARK DIAGNOSTICS, INC.Gram-Positive Blood Culture (BC-GP) Nucleic Acid Test Cartridge — NANOSPHERE, INC.Staph ID/R Blood Culture Panel — GREAT BASIN SCIENTIFIC, INC.Gram-Positive Blood Culture (BC-GP) Extraction Tray — NANOSPHERE, INC.LIAISON PLEX Gram-Positive Blood Culture Assay — LUMINEX CORPORATIONGram-Positive Blood Culture (BC-GP) Utility Tray — NANOSPHERE, INC.FilmArray® BCID Panel — BIOFIRE DIAGNOSTICS, LLCGram-Positive Blood Culture (BC-GP) Extraction Tray — LUMINEX CORPORATION
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-06-20 | Luminex Corporation | Potential for defective test cartridges which may result in false positive results for the Staphylococcus lugdunensis and Enterococcus faecium targets. |
| 2023-11-07 | Luminex Corporation | Potentially defective utility trays in the reagent kits. |
| 2020-10-13 | Luminex Corporation | Luminex has determined that three (3) separate test fixtures used by field service engineers to service the VERIGENE SP Processors were procured from unapproved |
| 2020-06-15 | Luminex Corporation | An instrument failure mode that may result in a Blood Culture Gram Positive (BC-GP) or Gram Negative (BC-GN) false negative call. |
| 2018-12-26 | Luminex Corporation | On lot of VERIGENE(R) BC-GP Utility Kits (20-011-018) were labeled with the VERIGENE(R) Amplification Tray label. |
| 2018-09-14 | Luminex Corporation | Potential to lead to a false negative results. |
| 2018-09-05 | BioFire Diagnostics, LLC | Increased risk of false positive results for Proteus when the product is used with a specific blood culture bottles. |
| 2016-12-12 | Great Basin Scientific, Inc. | The Great Basin Staph ID/R Panel is being recalled because the S. aureus probe could potentially result in a false positive. |
| 2014-05-27 | BioFire Diagnostics, Inc. | BioFire has identified an increased risk of false positive results when the FilmArray Blood Culture Identification (BCID) Panel is used with bioMrieux BacT/ALER |
| 2013-10-10 | Nanosphere, Inc. | Nanosphere has received several reports relating to an increased rate of Processing Errors during procedures performed on the Processor SP caused by Tips in Tip |
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