Altruan GmbH Strep A At-Home Tests Recalled for Lack of FDA Clearance

Agency Publication Date: March 12, 2026

Summary

Altruan GmbH is recalling 188 units of Wondfo, Clearest, and Bisaf brand Strep A at-home tests because they have not been cleared or approved by the FDA for safety and effectiveness. These diagnostic tests are used to detect group A streptococcal infections (Strep A) from throat swabs. Consumers should stop using these tests immediately and contact their healthcare provider for any diagnostic concerns.

Risk

Using a diagnostic test that has not been cleared by the FDA carries a risk of inaccurate results, including false negatives or false positives, which could lead to delayed treatment or unnecessary medical interventions.

What You Should Do

Stop using the recalled Strep A tests immediately.
Identify if you have an affected product by checking the brand and lot information: Wondfo Streptococcal A At-Home Self-Test (Model 41972, Lot 6933289812337), Clearest Strep-A Cassette Test (Model SP-C310343-10, Lot 01242573), or Bisaf Strep A Self-Test (Model AL-42153, Lot 6952804827274).
Stop using the product. Return it to the place of purchase for a refund or replacement, throw it away, or contact your healthcare provider or the manufacturer for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-463-6332 (1-888-INFO-FDA) for additional questions.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider, or return the product to the place of purchase for a refund or replacement

Option 2: Dispose of Product

How to: Stop using and throw the product away.

Affected Products

Product: Wondfo Streptococcal A At-Home Self-Testby Wondfo

Model / REF:

41972

Lot Numbers:

6933289812337

At-home test for group A beta-hemolytic streptococcal infection.

Product: Clearest Strep-A Cassette Testby Clearest

Model / REF:

SP-C310343-10

Lot Numbers:

01242573

Test to determine the presence of group A streptococci (Strep A) in throat swab samples.

Product: Bisaf Strep A Self-Testby Bisaf

Model / REF:

AL-42153

Lot Numbers:

6952804827274

Test for detection of group A streptococcal antigens in throat swabs.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 98472

Status: Active

Manufacturer: Altruan GmbH

Manufactured In: Germany

Units Affected: 3 products (188 units)

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Stop using the recalled Strep A tests immediately.

Identify if you have an affected product by checking the brand and lot information: Wondfo Streptococcal A At-Home Self-Test (Model 41972, Lot 6933289812337), Clearest Strep-A Cassette Test (Model SP-C310343-10, Lot 01242573), or Bisaf Strep A Self-Test (Model AL-42153, Lot 6952804827274).

Stop using the product. Return it to the place of purchase for a refund or replacement, throw it away, or contact your healthcare provider or the manufacturer for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-463-6332 (1-888-INFO-FDA) for additional questions.

Affected Products

Product: Wondfo Streptococcal A At-Home Self-Testby Wondfo

Model / REF:

41972

Lot Numbers:

6933289812337

At-home test for group A beta-hemolytic streptococcal infection.

Product: Clearest Strep-A Cassette Testby Clearest

Model / REF:

SP-C310343-10

Lot Numbers:

01242573

Test to determine the presence of group A streptococci (Strep A) in throat swab samples.

Product: Bisaf Strep A Self-Testby Bisaf

Model / REF:

AL-42153

Lot Numbers:

6952804827274

Test for detection of group A streptococcal antigens in throat swabs.