Z-2033-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- June 19, 2024
- Initiation Date
- April 22, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 102,500 units
Product Description
Independent Medical Co-op Inc., Streptococcal A rapid test kits, labeled as: IMCO Strep A Rapid Test Strip and IMCO Strep A Rapid Test, Part Number STP25-IMC
Reason for Recall
Wondfo USA has identified unauthorized distribution of the Preview Strep A Test Kit. Unauthorized distribution of this device would include sales and distribution of this test for at-home use, non-prescription use, over-the-counter use, or direct-to-consumer customers.
Distribution Pattern
US Nationwide distribution.
Code Information
Lot Numbers: W039301002, W039306002, W039312001, W03920403, W03920708, W03921003, W03921007