—#215204

Product

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

FDA product code: GTY — Antigens, All Groups, Streptococcus Spp.
Device class: Class 1
Medical specialty: Microbiology
510(k) numbers: K010582
Affected lot / code info: Catalog Number: 4581225020. GTIN: 10815845020024. All lot numbers

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.

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: Mckesson Medical-Surgical Inc. Corporate Office 9954 Maryland Drive Deep Run Iii Ste. 4000 Richmond VA 23233

Distribution

Distribution pattern: US Nationwide distribution in the state of Georgia.

Timeline

Recall initiated: 2025-07-30
Posted by FDA: 2025-08-18
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #215204. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.