FDA Enforcement
Class II
Ongoing
Clarity and Clarity Diagnostics LLC, Streptococcal A rapid test kits, Labeled as: a) Clarity Strep A Rapid Test, Part Number CD-STP25, b) Clarity Diagnostics LLC, Clarity Strep A Rapid Test, Part Number CD-STP25V
Recall: Z-2031-2024
·
Reported June 19, 2024
Enforcement
- Recall Number
- Z-2031-2024
- 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
Clarity and Clarity Diagnostics LLC, Streptococcal A rapid test kits, Labeled as: a) Clarity Strep A Rapid Test, Part Number CD-STP25, b) Clarity Diagnostics LLC, Clarity Strep A Rapid Test, Part Number CD-STP25V
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
a) CD-STP25, Lot Numbers: W03920402, W03920603, W03920707, W03921002, W03921006, W039301001, W039302001, W039302003, W039306003; b) CD-STP25V, Lot Numbers: CD-STP25V W03920404, W039302002
Distribution
US Nationwide distribution.
Quantity
170,000 units