Medical device recalls Moderate risk

Mckesson Medical-Surgical Inc. Corporate Office recalls Quantimetrix Urine Chemistry Control Set Dipper Urinalysis Dipstick Testing Levels 1 & 2 6 X 15 mL-IVD intended as a co…

Recall date
September 17, 2024
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0138-2025
FDA classification
Class II
Brand / firm
Mckesson Medical-Surgical Inc. Corporate Office
Sold / distributed
US Nationwide distribution in the state of DC.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.

Get recall alerts

Free email alert whenever Mckesson Medical-Surgical Inc. Corporate Office has a new recall — straight from official government data. Unsubscribe anytime.

More recalls from: Mckesson Medical-Surgical Inc. Corporate Office