Streptococcal A Rapid Test Kits Recalled for Unauthorized Distribution
Wondfo USA has recalled 170,000 units of Clarity Strep A Rapid Test kits due to unauthorized distribution for at-home use, non-prescription use, over-the-counter use, and direct-to-consumer sales. The recall affects test kits distributed nationwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II classification indicates potential for adverse health consequences. The unauthorized distribution of a diagnostic test for at-home use without professional oversight creates a risk of diagnostic error and improper result interpretation, though no illnesses or injuries have been reported.
Plain-English summary
Wondfo USA is recalling approximately 170,000 units of Clarity Strep A Rapid Test kits. The affected products are Clarity Strep A Rapid Test Part Number CD-STP25 and Part Number CD-STP25V, with specific lot numbers identified in the recall. The test kits were distributed nationwide in the United States.
The recall was initiated due to unauthorized distribution of the test kits. The products have been sold or distributed for at-home use, non-prescription use, over-the-counter use, and direct-to-consumer customers. These distribution methods are not authorized for this medical device.
The Clarity Strep A Rapid Test is a diagnostic test intended for the detection of Streptococcal A infection. Distribution of the test for at-home and over-the-counter use without appropriate professional guidance raises concerns regarding proper test performance and interpretation of results.
Persons who have obtained the recalled test kits from unauthorized distributors should not use them for at-home testing. Consumers should consult with a healthcare provider regarding appropriate testing for Streptococcal A infection. Contact Wondfo USA for instructions regarding the recalled product.
The recalled product
- 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
- Manufacturer
- Wondfo USA Co Ltd
- Category
- Medical Device — Diagnostic Test
- Hazard
- diagnostic-error
- unauthorized-distribution
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (13)
- a) CD-STP25
- Lot Numbers: W03920402
- W03920603
- W03920707
- W03921002
- W03921006
- W039301001
- W039302001
- W039302003
- W039306003
- b) CD-STP25V
- Lot Numbers: CD-STP25V W03920404
- W039302002
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- CriticalMedline spinal anesthetic kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03
- SevereMedline spinal anesthesia kits recalled for bupivacaine quality issues
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Trays Recalled Due to Quality and Efficacy Concerns
FDA (Devices) · 2026-06-03
- HighMedline Medical Convenience Kit Recalled: Wrong Syringe Type Inside
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Block Kits Recalled for Data Integrity and Efficacy Issues
FDA (Devices) · 2026-06-03