Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Wondfo Streptococcal A At-Home Self-Test. At-home test for group A Recalled by Altruan GmbH Due to Product not cleared by the FDA.

Date: December 19, 2025
Company: Altruan GmbH
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Altruan GmbH directly.

Affected Products

Wondfo Streptococcal A At-Home Self-Test. At-home test for group A beta-hemolytic streptococcal infection.

Quantity: 188 units

Why Was This Recalled?

Product not cleared by the FDA.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Altruan GmbH

Altruan GmbH has 3 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report