BinaxNOW Respiratory Strep A Test Kit — Class II medical device recall Z-3184-2024
Ongoing recall by Cypress Medical Products LLC, reported 2024-09-25, distributed nationwide. Due to a classification error in our inventory management system, these medical devices were shipped to custom
| Recall number | Z-3184-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cypress Medical Products LLC, Richmond, VA, United States |
| Recall initiated | 2024-08-20 |
| Classified | 2024-09-19 |
| Reported by FDA | 2024-09-25 |
| Distributed | Nationwide (US) |
| Quantity | 15 kits |
| UPC / GTIN / UDI-DI | 10811877010453 |
| Model numbers | 730025 |
Product
BinaxNOW Respiratory Strep A Test Kit, CLIA Waived, Catalog Number 730025
Reason for recall
Due to a classification error in our inventory management system, these 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-3184-2024. 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.