FDA-Device2025-08-27Class II

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

Mckesson Medical-Surgical Inc. Corporate Office
Hazard

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.

Sold states
US Nationwide distribution in the state of Georgia.
Affected count
5 kits
Manufactured in
9954 Maryland Drive, Deep Run Iii Ste. 4000, Richmond, VA, United States
Products
Clearview Strep A Exact II Dipstick Respiratory Kit, CLIA Waived. Catalog Number: 4581225020

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2337-2025

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