Device product
Clearview Strep A Exact II Dipstick Respiratory Kit, CLIA Waived. Catalog Number: 4581225020
Z-2337-2025
Product summary
- Event
- Event 97315
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 5 kits
- Official record key
device-enforcement:Z-2337-2025
Official wording
Reason: 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.
Code information: Catalog Number: 4581225020. GTIN: 10815845020024. All lot numbers
Distribution pattern: US Nationwide distribution in the state of Georgia.
Derived failure modes
-
Unknown
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.