Lower riskMedical device recall · FDA · Published July 30, 2025
Clearview Strep A Exact II Dipstick Respiratory Kit Recall: License Classification Error
Mckesson Medical-Surgical recalls Clearview Strep A Exact II Dipstick Respiratory Kit (Catalog 4581225020) due to shipping devices without proper license classification. All units are affected.
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.
Take action
Contact the company
📍Recalling firmMckesson Medical-Surgical Inc. Corporate Office9954 Maryland Drive, Deep Run Iii Ste. 4000 · Richmond, VA 23233
“Clearview Strep A Exact II Dipstick Respiratory Kit Recall: License Classification Error.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/51714-clearview-strep-a-exact-ii-dipstick-respiratory-kit-recall-license. Based on FDA recall #Z-2337-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2337-2025%22&limit=1).
The FDA announced on July 30, 2025, that Mckesson Medical-Surgical Inc. Corporate Office is recalling Clearview Strep A Exact II Dipstick Respiratory Kits due to a classification error in the inventory management system. The hazard involves shipping devices to customers without the requisite license to purchase them.
How to tell if you have it
Brand: Mckesson Medical-Surgical
Product: Clearview Strep A Exact II Dipstick Respiratory Kit, CLIA Waived
Catalog Number: 4581225020
UPC: 10815845020024
Lot numbers: All lot numbers
Distribution: US Nationwide distribution in the state of Georgia
The hazard
According to the FDA, specific medical devices were shipped to customers that did not have the requisite license to purchase such devices due to a classification error in the inventory management system.
Context
GovInfoNow's records show Mckesson Medical-Surgical Inc. Corporate Office has 14 other recalls on record since June 2, 2021. Other recent recalls of similar products include Baxter Infuvite Adult Recall (April 25, 2025), Abbott Cholestech LDX Lipid Profile Glucose Test Kits (April 24, 2025), and EVENITY Injection Recall (April 21, 2025).
How to tell if you have this one
Check for the Catalog Number 4581225020 on the kit. All lot numbers are affected. The kit has GTIN 10815845020024.
Brand
Mckesson Medical-Surgical
Product
Clearview Strep A Exact II Dipstick Respiratory Kit, CLIA Waived. Catalog Number: 4581225020
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check License Status
Verify if your healthcare facility has the proper license to use this kit before continuing use.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “US Nationwide distribution in the state of Georgia.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 28 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2337-2025 (July 30, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2337-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.