Gram-Positive Blood Culture (BC-GP) Extraction Tray 20-009-018Recalls & reported problems
Luminex Corporation · 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). · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840487101629), received between Oct 16, 2023 and Oct 16, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Volume Accuracy Problem” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Volume Accuracy Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 16, 2023Volume Accuracy Problem; Volume Accuracy Problem
(B)(4). UPON FURTHER INSPECTION, LOWER VOLUMES OF THE LABIASE ENZYME WERE OBSERVED IN WELL 2 OF THE UTILITY TRAY, AS SHOWN IN FIGURE 1 (ATTACHED). ONE OF THE TRAYS HAD A VISIBLY LOWER VOLUME OF REAGENT IN WELL 2, COMPARED TO THE PRODUCT SPECIFICATION OF 100±10 MICROLITERS. NC-04966 AND HRA-23-0033 WERE INITIATED FOR THE NONCONFORMING MATERIAL. THERE WERE NO FALSE RESULTS OBSERVED DURING FINAL PRODUCT TESTING FOR LOT 062123018C. THE LABIASE ENZYME IN THE VERIGENE BC-GP ASSAY IS AN ENZYME PREPARATION USEFUL FOR THE LYSIS OF ENTEROCOCCUS BACTERIA. WITHIN NC-04966, IT WAS DETERMINED THAT LOW VOLUMES OF THE LABIASE ENZYME COULD RESULT IN FALSE-NEGATIVE RESULTS, IMPACTING E. FAECALIS, E. FAECIUM, VANA, AND VANB.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17940622 ↗
Other Gram-positive bacteria and their resistance markers devices
- BioFire® Blood Culture Identification 2 (BCID2) Panel RFIT-ASY-0147Biofire Diagnostics, LLC · Gram-Positive Bacteria And Their Resistance Markers6 recalls6 deaths555 reports
- Gram-Positive Blood Culture (BC-GP) Nucleic Acid Test Cartridge 20-006-018Luminex Corporation · Gram-positive bacteria and their resistance markers1 recall1 death15 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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