MAUDE manufacturer profile
ABBOTT MOLECULAR, INC. · OOI
MAUDE profile for Real Time Nucleic Acid Amplification System
Key facts
| Manufacturer | ABBOTT MOLECULAR, INC. |
|---|---|
| Manufacturer group | ABBOTT MOLECULAR, INC. |
| Product code | OOI |
| Product code name | Real Time Nucleic Acid Amplification System |
At a glance
- 100–999 MAUDE reports
- 1–9 Injury reports
- 100–999 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Clinical Signs, Symptoms or Conditions, Program or Algorithm Execution Problem, Fluid/Blood Leak, Device Dislodged or Dislocated, Unable to Obtain Readings, Mechanical Problem, Incorrect, Inadequate or Imprecise Result or Readings, False Positive Result 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