Medical Device Recall: 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
Mckesson Medical-Surgical Inc. Corporate Office · September 17, 2024
Reason for Recall
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.
Product Description
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.
Distribution
US Nationwide distribution in the state of DC.
States Affected
NATIONWIDE
Quantity Affected
1 BOX
Source: FDA (openFDA Device Enforcement)
Recall number: Z-0138-2025
Status: ongoing
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