MAUDE manufacturer profile
HOLOGIC, INC. · QJR
MAUDE profile for Reagents, 2019-Novel Coronavirus Nucleic Acid
Key facts
| Manufacturer | HOLOGIC, INC. |
|---|---|
| Manufacturer group | HOLOGIC, INC. |
| Product code | QJR |
| Product code name | Reagents, 2019-Novel Coronavirus Nucleic Acid |
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, Erratic Results, No Apparent Adverse Event, Off-Label Use, Device Contaminated at the User Facility, Improper or Incorrect Procedure or Method, Low 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