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Gram-Positive Blood Culture (BC-GP) Nucleic Acid Test Cartridge
LUMINEX CORPORATION · Model 20-006-018 · UDI-DI 00840487101575
7
510(k) clearances
628
Adverse events (8 deaths)
11
Recalls
4
Facilities
Description
The Verigene® Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) performed using the sample-to-result Verigene® System is a qualitative, multiplexed in vitro diagnostic test for the simultaneous detection and identification of potentially pathogenic gram-positive bacteria which may cause bloodstream infection (BSI).
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 sources and, in som |
| 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/ALERT Standard Anaerobic |
| 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 Holder Assemblies f |
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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.