Clearview Strep A Exact II Dipstick Respiratory Kit — Class II medical device recall Z-2337-2025
Ongoing recall by Mckesson Medical-Surgical Inc. Corporate Office, reported 2025-08-27, distributed nationwide. Due to a classification error in the inventory management system, specific medical devices were shipped to cus
| Recall number | Z-2337-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mckesson Medical-Surgical Inc. Corporate Office, Richmond, VA, United States |
| Recall initiated | 2025-07-30 |
| Classified | 2025-08-18 |
| Reported by FDA | 2025-08-27 |
| Distributed | Nationwide (US) |
| Quantity | 5 kits |
| UPC / GTIN / UDI-DI | 10815845020024 |
| Model numbers | 4581225020 |
Product
Clearview Strep A Exact II Dipstick Respiratory Kit, CLIA Waived. Catalog Number: 4581225020
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2337-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.