Altruan Gmbh Morolding 6 Massing Germany: Antigens, All Groups, Streptococcus Spp.
- Recalling firm
- Altruan GmbH Morolding 6 Massing Germany
- Product
- Brand Name: Bisaf Strep A Self-Test. Test for detection of group A streptococcal antigens in throat swabs.
- 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/f9cd590c-3095-4fe0-af1e-c247971e1db1