Altruan Gmbh Morolding 6 Massing Germany: Antigens, All Groups, Streptococcus Spp.
- Recalling firm
- Altruan GmbH Morolding 6 Massing Germany
- Product
- Wondfo Streptococcal A At-Home Self-Test. At-home test for group A beta-hemolytic streptococcal infection.
- Reason
- Product not cleared by the FDA.
- Classification
- Class I
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2025-12-19
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- US Nationwide distribution.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/3cd0f291-c1e9-4307-ba10-68e33214de15