FDA Adverse Event
Malfunction
Summary report: N
URINARY TRACT INFECTION TEST STRIPS
MDR report key: 23109694
·
Received September 22, 2025
Report
- Report Number
- MW5176290
- Event Type
- Malfunction
- Date Received
- September 22, 2025
- Report Date
- September 16, 2025
- Manufacturer
- I-HEALTH, INC.
- Product Code
- LJX
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Occupation
- UNKNOWN
- Health Professional
- *
Narratives
Description of Event or Problem · 0
PRODUCT IS MISLEADING TO TEST FOR UTI'S. INSTRUCTIONS ON BOX AND PRODUCT INSIDE HAVE OPPOSITE INSTRUCTIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2655360 | URINARY TRACT INFECTION TEST STRIPS | TEST, URINE LEUKOCYTE | LJX | I-HEALTH, INC. | ATBM12522 | 25181ASM12 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Male |