FDA Medical devices recall ·
Clearview Strep A Exact II Dipstick Respiratory Kit, CLIA Waived recall
- Recall number
- Z-2337-2025
- Date
- (initiated July 30, 2025)
- Company / brand
- Mckesson Medical-Surgical Inc. Corporate Office
9954 Maryland Drive, Richmond, VA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 5 kits
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Clearview Strep A Exact II Dipstick Respiratory Kit, CLIA Waived. Catalog Number: 4581225020
Why was it 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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Catalog Number: 4581225020. GTIN: 10815845020024. All lot numbers
Distribution
US Nationwide distribution in the state of Georgia.
States: Georgia
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2337-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.