Streptococcal A Rapid Test Kits Recalled for Unauthorized At-Home Distribution
Wondfo USA recalls Areta Strep A test kits (Lot E03920802) distributed for unauthorized at-home and over-the-counter use. The recall affects 75,000 units distributed nationwide.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a Class II medical device with no reported illnesses or injuries. The issue is unauthorized distribution for at-home and over-the-counter use, representing a labeling and regulatory compliance matter without a demonstrated product defect or safety incident.
Plain-English summary
Wondfo USA Co Ltd has identified unauthorized distribution of Areta Strep A Swab Test kits (Part Number ARST-100, also labeled as Areta One Step Strep A Swab Test). The unauthorized distribution includes sales and distribution for at-home use, non-prescription use, over-the-counter use, or direct-to-consumer sales.
The recall affects 75,000 units (Lot Number E03920802) distributed nationwide in the United States. This Class II device recall addresses units distributed outside their authorized use classification.
Consumers who have obtained this test through unauthorized channels should be aware of this recall.
The recalled product
- Product
- 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
- Manufacturer
- Wondfo USA Co Ltd
- Category
- Medical Device — Diagnostic Test
- Affected units
- 75,000
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)
- Lot Numbers: E03920802
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
FDA (Devices) · 2024-06-19
- ModerateStrep A Rapid Test Kits Recalled for Unauthorized Distribution
FDA (Devices) · 2024-06-19
- HighStreptococcal A Rapid Test Kits Recalled for Unauthorized At-Home Distribution
FDA (Devices) · 2024-06-19
- HighStreptococcal A Rapid Test Kits Recalled for Unauthorized Distribution
FDA (Devices) · 2024-06-19
Same hazard · mis labeling
See all →- SevereImperio Distribution Recalls Beef Jerky Produced Without Federal Inspection
USDA FSIS · 2026-10-24
- ModerateHealthmark Vinyl Instrument Guards Recalled for Labeling Non-Compliance
FDA (Devices) · 2026-10-21
- ModerateGore Viabil Short Wire Biliary Endoprosthesis Recalled for Incorrect Length Labeling
FDA (Devices) · 2026-10-21
- ModerateIn2bones Recalls Partially Threaded Bone Screws Due to Labeling Error
FDA (Devices) · 2026-10-21
- SevereInstrumentation Laboratory Recalls HemoslL AcuStar HIT-lgG In Vitro Diagnostic Reagents
FDA (Devices) · 2026-10-21
Similar recalls
- ModerateWondfo Streptococcal A self-test recalled because it lacks FDA clearance
FDA (Devices) · 2026-03-18
- ModerateStrep A test kits recalled after shipment to unlicensed purchasing customers
FDA (Devices) · 2025-08-27
- ModerateLumiQuick Strep A Test Card Recalled for Unauthorized Distribution
FDA (Devices) · 2014-04-16
- ModerateBinaxNOW Respiratory Strep A Test Kits Shipped to Unlicensed Purchasers
FDA (Devices) · 2024-09-25
- ModerateBisaf Strep A self-test recalled because it lacks FDA clearance
FDA (Devices) · 2026-03-18
- ModerateOne Step 10A In Vitro Diagnostic Test Distributed Without FDA Clearance
FDA (Devices) · 2026-05-13