FDA recall, , Moderate risk
Altruan Strep A At-Home Self-Tests
Altruan GmbH is recalling its Wondfo Streptococcal A At-Home Self-Test, Clearest Strep-A Cassette Test, and Bisaf Strep A Self-Test because of product not cleared by the FDA.
Summary by Recall Canary from the FDA notice
What happened
Altruan GmbH, based in Massing, Germany, is recalling its Wondfo Streptococcal A At-Home Self-Test, Clearest Strep-A Cassette Test, and Bisaf Strep A Self-Test because the products were not cleared by the FDA. The recall began December 19, 2025, and was added to the FDA's Enforcement Report on March 12, 2026. The products were distributed nationwide in the US.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is your cassette affected?
3 products
Affected if its UDI-DI is listed.
A UDI-DI is the device identifier printed with the barcode on the device label.
Wondfo Streptococcal A At-Home Self-Test. At-home test for group A beta-hemolytic streptococcal infection.
- UDI-DI
- 6933289812337
Brand Name: Bisaf Strep A Self-Test. Test for detection of group A streptococcal antigens in throat swabs.
- UDI-DI
- 6952804827274
Clearest Strep-A Cassette Test. Test to determine the presence of group A streptococci (Strep A) in throat swab samples.
- UDI-DI
- 01242573
Recall details
- Company began the recall
- Sold in
US Nationwide distribution.
- Company
- Altruan GmbHMassing, Germany
- Hazard
- Unapproved product
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98472
- Recall numbers
- Z-1559-2026 to Z-1561-2026
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
