Medical device recalls Moderate risk

Mckesson Medical-Surgical Inc. Corporate Office recalls Clearview Strep A Exact II Dipstick Respiratory Kit, CLIA Waived. Catalog Number: 4581225020

Recall date
July 30, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2337-2025
FDA classification
Class II
Brand / firm
Mckesson Medical-Surgical Inc. Corporate Office
Sold / distributed
US Nationwide distribution in the state of Georgia.

Why it was recalled

Due to a classification error in the inventory management system, specific medical devices were shipped to customers that did not have the requisite license to purchase such devices.

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

What was recalled

Clearview Strep A Exact II Dipstick Respiratory Kit, CLIA Waived. Catalog Number: 4581225020

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