Recall Weekly
Moderate riskFDA DeviceClass II

Wondfo strep A at-home test recalled for lack of FDA clearance

Wondfo Streptococcal A At-Home Self-Test kits were distributed in the US without FDA clearance. This means the test's accuracy and safety have not been verified by the FDA. If you have this test, results may not be reliable.

From the FDA notice · Read the official notice ↗

What to do

  1. Stop using the test kit immediately
  2. Do not rely on results from this test for medical decisions
  3. Contact your healthcare provider if you think you have strep A
  4. Dispose of the kit safely or contact the manufacturer for return instructions
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Wondfo Streptococcal A At-Home Self-Test. At-home test for group A beta-hemolytic streptococcal infection.
Sold in
Nationwide
Made for
All ages (under 100 years)

This recall covers 3 products — see all of them.

Details

Units affected
188 units
Illnesses reported
None reported
Manufactured in
Morolding 6, N/A, Massing, N/A, Germany
Classification
Class II
Recall number
Z-1559-2026

In the FDA's words

Description
Wondfo Streptococcal A At-Home Self-Test. At-home test for group A beta-hemolytic streptococcal infection. Product not cleared by the FDA. Model No. 41972; No UDI; Lot Code: 6933289812337. Distribution: US Nationwide distribution. Affected quantity: 188 units
Hazard
Product not cleared by the FDA.

3 products in this recall

Altruan Strep A tests recalled for lacking FDA clearance

Altruan is recalling three Strep A test products, including the Wondfo Streptococcal A At-Home Self-Test, Clearest Strep-A Cassette Test, and Bisaf Strep A Self-Test. The tests were distributed nationwide and the FDA has not cleared them. No injuries have been reported.

The agency lists each product separately. Check every one you might have.

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