Mckesson Medical-Surgical Inc. Corporate Office recalls Clearview Strep A Exact II Dipstick Respiratory Kit

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.

McKesson notified consignees on about 07/30/2025 via overnight mail. Consignees were instructed to immediately examine inventory and quarantine all affected units, complete and return the provided response form, and destroy any affected products. If affected product was further distributed, consignees were instructed to notify their customers.

• FDA enforcement recordOfficial FDA database entry for Z-2337-2025
• FDA 510(k) clearance · K010582The device's official FDA premarket clearance record
• FDA device classification · GTYOfficial FDA classification for this device type
• CFR regulation · 21 CFR 866.3740The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Mckesson Medical-Surgical Inc. Corporate OfficeSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.