FDA Adverse Event
Malfunction
Summary report: N
FASTEP COVID-19 ANTIGEN HOME TEST
MDR report key: 20635475
·
Received November 7, 2024
Report
- Report Number
- 3014862351-2024-00007
- Event Type
- Malfunction
- Date Received
- November 7, 2024
- Report Date
- November 7, 2024
- Manufacturer
- AZURE BIOTECH, INC.
- Product Code
- QYT
- UDI-DI
- 00810022630358
- PMA / PMN Number
- EUA220191
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
CUSTOMER CONTACTED FOR A REFUND/ REPLACEMENT THROUGH AMAZON, BUT NO RESPONSE WAS PROVIDED.
Description of Event or Problem · 0
PARENT HAS GIVEN FEEDBACK THAT THEIR PRESCHOOLER HAS FALSELY TESTED POSITIVE DURING TWO DIFFERENT PERIODS IN A MATTER OF 30 DAYS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1951569 | FASTEP COVID-19 ANTIGEN HOME TEST | FASTEP COVID-19 ANTIGEN HOME TEST | QYT | AZURE BIOTECH, INC. | I2301009) | 00810022630358 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 4 YR | Prefer Not To Disclose |