Class II

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

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.