Z-2337-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- August 27, 2025
- Initiation Date
- July 30, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5 kits
Product Description
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.
Distribution Pattern
US Nationwide distribution in the state of Georgia.
Code Information
Catalog Number: 4581225020. GTIN: 10815845020024. All lot numbers