FDA Enforcement
Class II
Ongoing
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
Recall: Z-2033-2024
·
Reported June 19, 2024
Enforcement
- Recall Number
- Z-2033-2024
- Event ID
- 94261
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Wondfo USA Co Ltd
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- June 19, 2024
- Initiation Date
- April 22, 2024
- Classification Date
- June 7, 2024
- Address
- 545 Willowbrook Center Pkwy Ste B, N/A, Willowbrook, IL, 60527-8436, United States
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
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.
Code Info
Lot Numbers: W039301002, W039306002, W039312001, W03920403, W03920708, W03921003, W03921007
Distribution
US Nationwide distribution.
Quantity
102,500 units