FDA recall Z-2337-2025

Mckesson Medical-Surgical Inc. Corporate Office · Class II · device

Product

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

Reason for recall

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.

Distribution

US Nationwide distribution in the state of Georgia.

Key facts

Status: Ongoing
Initiation date: 2025-07-30
Report date: 2025-08-27
Voluntary/Mandated: Voluntary: Firm initiated
Location: Richmond, VA, United States

Primary source

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