MAUDE manufacturer profile
BIOFIRE DIAGNOSTICS, LLC · PCH
MAUDE profile for Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System
Key facts
| Manufacturer | BIOFIRE DIAGNOSTICS, LLC |
|---|---|
| Manufacturer group | BIOFIRE DIAGNOSTICS, LLC |
| Product code | PCH |
| Product code name | Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System |
At a glance
- 10–99 MAUDE reports
- 1–9 Death reports
- 1–9 Injury reports
- 10–99 Malfunction reports
- 1–9 Problems flagged by Orca1 signal analytics
- False Positive Result, Insufficient Information, No Clinical Signs, Symptoms or Conditions, No Known Impact Or Consequence To Patient, Incorrect, Inadequate or Imprecise Result or Readings, False Negative Result, Sepsis, Death Most reported problems
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About MAUDE manufacturer and product code profiles
Manufacturer profiles aggregate MAUDE reports for one manufacturer within one product code, the level at which device safety signals are usually reviewed.
Source: U.S. Food and Drug Administration (FDA), MAUDE database; aggregation by Orca1