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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Diagnostic Equipment

Clearview Strep A Test Kits Recalled for Shipment to Unlicensed Customers

Agency Publication Date: August 18, 2025
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Summary

McKesson Medical-Surgical Inc. is recalling 5 kits of Clearview Strep A Exact II Dipstick Respiratory Kits because they were mistakenly shipped to customers who did not have the required medical licenses to purchase or use them. This distribution error was caused by a classification mistake in the company's inventory management system. The recall affects kits with Catalog Number 4581225020 and all lot numbers. Laboratory supervisors and healthcare facilities should stop using these kits immediately and contact the manufacturer to arrange for their return.

Risk

The shipment of medical diagnostic devices to unlicensed facilities creates a risk that the tests could be performed or interpreted by individuals without the proper training or oversight. This could potentially lead to incorrect medical decisions or improper patient care.

What You Should Do

  1. This recall affects Clearview Strep A Exact II Dipstick Respiratory Kits (CLIA Waived) sold under Catalog Number 4581225020 and GTIN 10815845020024.
  2. Check the catalog and GTIN numbers on the product packaging; all lot numbers for this specific catalog number are included in this recall.
  3. Stop using the recalled product immediately.
  4. Contact McKesson Medical-Surgical Inc. or your distributor to arrange for the return, replacement, or correction of the affected kits.
  5. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional questions regarding this medical device recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Clearview Strep A Exact II Dipstick Respiratory Kit, CLIA Waived
Model / REF:
4581225020
Lot Numbers:
All lot numbers
GTIN:
10815845020024

Quantity affected: 5 kits. Affected due to a classification error in the inventory management system.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97315
Status: Active
Manufacturer: Mckesson Medical-Surgical Inc. Corporate Office
Sold By: McKesson Medical-Surgical Inc.
Manufactured In: United States
Units Affected: 5 kits
Distributed To: Georgia

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.