Clearview Strep A Kit (Mckesson) – classification error (2025)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Clearview Strep A Exact II Dipstick Respiratory Kit, CLIA Waived. Catalog Number: 4581225020
Brand
Mckesson Medical-Surgical Inc. Corporate Office 9954 Maryland Drive Deep Run Iii Ste. 4000 Richmond VA 23233
Lot Codes / Batch Numbers
Catalog Number: 4581225020. GTIN: 10815845020024. All lot numbers
Products Sold
Catalog Number: 4581225020. GTIN: 10815845020024. All lot numbers
Mckesson Medical-Surgical Inc. Corporate Office 9954 Maryland Drive Deep Run Iii Ste. 4000 Richmond VA 23233 is recalling Clearview Strep A Exact II Dipstick Respiratory Kit, CLIA Waived. Catalog Number: 4581225020 due to Due to a classification error in the inventory management system, specific medical devices were shipped to customers that did not have the requisite l. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026