Z-2034-2024 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
- N/A
Product Description
Streptococcal A rapid test kits, labeled as: Wondfo Biotech Co., Ltd, WondView Strep A Test Kit, Guangzhou Wondfo Biotech Co., Ltd, Wondfo One Step Strep A Swab Test, Dealmed Medical Supplies LLC, Strep A Rapid Test Kit, Jant Pharmacal Corporation, Accustrip VALUPAK Strep A Test Strip, SMC Direct, LLC, RefuAH Strep A Rapid,
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
part numbers and lot numbers are unknown