Recall Z-2031-2024— Wondfo USA Co Ltd
Class II · Ongoing
Class II FDA medical device recall by Wondfo USA Co Ltd, initiated 2024-04-22. FDA's recall record names no specific 510(k) clearance for this event. Product: 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..
- Recalling firm
- Wondfo USA Co Ltd
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-04-22
- Firm location
- Willowbrook, IL, United States
Product 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 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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.