FDA Device recall Z-3184-2024
BinaxNOW Respiratory Strep A Test Kit, CLIA Waived, Catalog Number 730025
- FDA Device
- Class II
- ongoing
- Published 2024-09-25
On 2024-09-25 the FDA classified a Class II recall of BinaxNOW Respiratory Strep A Test Kit, CLIA Waived, Catalog Number 730025 by Cypress Medical Products, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3184-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-08-20 |
| Published | 2024-09-25 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Cypress Medical Products |
| Distribution | US |
Product
BinaxNOW Respiratory Strep A Test Kit, CLIA Waived, Catalog Number 730025
Reason
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.
Identifiers
| code_info | GTIN: 10811877010453; All Lots |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3184-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.