Z-3184-2024 Class II Ongoing
FDA device recall Z-3184-2024 was initiated by Cypress Medical Products LLC on August 20, 2024 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 15 kits.
Recall Details
- Product Type
- Devices
- Report Date
- September 25, 2024
- Initiation Date
- August 20, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 15 kits
Product Description
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.
Distribution Pattern
US Nationwide distribution.
Code Information
GTIN: 10811877010453; All Lots