Streptococcal A Rapid Test Kits Recalled for Unauthorized At-Home Distribution
Wondfo USA has recalled Streptococcal A rapid test kits that are being sold for unauthorized at-home and direct-to-consumer use. The kits should not be used outside professional healthcare settings.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: This is an FDA Class II recall with no reported hospitalizations or injuries. The risk of harm from unauthorized at-home distribution of a diagnostic test that requires professional interpretation qualifies this as High severity per the rubric.
Plain-English summary
Wondfo USA Co Ltd has initiated a recall of Streptococcal A rapid test kits distributed under multiple brand names, including WondView Strep A Test Kit, Wondfo One Step Strep A Swab Test, Dealmed Strep A Rapid Test Kit, Jant Pharmacal Accustrip VALUPAK Strep A Test, and SMC Direct RefuAH Strep A Rapid Test.
The manufacturer has identified that these test kits are being distributed for unauthorized uses, including at-home use, non-prescription use, over-the-counter sale, and direct-to-consumer distribution. These diagnostic tests are intended for professional healthcare use only.
The affected test kits have been distributed nationwide throughout the United States.
Consumers who have purchased or received one of these products should not use them outside of professional healthcare settings. Consult with a healthcare provider for appropriate testing and diagnosis.
The recalled product
- Product
- 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…
- Manufacturer
- Wondfo USA Co Ltd
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 (1)
- part numbers and lot numbers are unknown
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 5 recalled by Wondfo USA Co Ltd under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 5 products in this recall →Related recalls
Same manufacturer · Wondfo USA Co Ltd
See all →- HighStreptococcal A Rapid Test Kits Recalled for Unauthorized Distribution
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- HighStreptococcal A Rapid Test Kits Recalled for Unauthorized Distribution
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