FDA Enforcement
Class II
Ongoing
BinaxNOW Respiratory Strep A Test Kit, CLIA Waived, Catalog Number 730025
Recall: Z-3184-2024
·
Reported September 25, 2024
Enforcement
- Recall Number
- Z-3184-2024
- Event ID
- 95235
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Cypress Medical Products LLC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- September 25, 2024
- Initiation Date
- August 20, 2024
- Classification Date
- September 19, 2024
- Address
- 9954 Mayland Dr, Richmond, VA, 23233-1464, United States
Description
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.
Code Info
GTIN: 10811877010453; All Lots
Distribution
US Nationwide distribution.
Quantity
15 kits