Wondfo USA Co Ltd: Device Recall
Recall #Z-2032-2024 · 04/22/2024
Class II: Risk
Recall Details
- Recall Number
- Z-2032-2024
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Wondfo USA Co Ltd
- Status
- Ongoing
- Date Initiated
- 04/22/2024
- Location
- Willowbrook, IL, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 75,000 units
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.
Product Description
Streptococcal A rapid test kits, labeled as: Easy Healthcare Corporation, Areta Strep A Swab Test and EASY at Home Medical LLC, Areta One Step Strep A Swab Test, Part Number ARST-100
Distribution Pattern
US Nationwide distribution.
Other Recalls by Wondfo USA Co Ltd
- Class II: Risk 04/22/2024
- Class II: Risk 04/22/2024
- Class II: Risk 04/22/2024
- Class II: Risk 04/22/2024
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.