Device product
Quantimetrix Urine Chemistry Control Set Dipper Urinalysis Dipstick Testing Levels 1 & 2 6 X 15 mL-IVD intended as a control for urinalysis reagent strips, microalbumin, and creatinine by listed test methods.
Z-0138-2025
Product summary
- Event
- Event 95410
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1 BOX
- Official record key
device-enforcement:Z-0138-2025
Official wording
Reason: The Quantimetrix Dipper Urinalysis Dipstick control was shipped without the validated summer packaging and may have been exposed to temperatures above 25¿C. This may lead to delay in patients' results.
Code information: UDI-DI: 896863002134
Distribution pattern: US Nationwide distribution in the state of DC.
Derived failure modes
-
Unknown
The Quantimetrix Dipper Urinalysis Dipstick control was shipped without the validated summer packaging and may have been exposed to temperatures above 25¿C. This may lead to delay in patients' results.