Brand Name: Bisaf Strep A Self-Test. Test for detection recall
Brand Name: Bisaf Strep A Self-Test. Test for detection of group A streptococcal antigens in throat swabs.
Why was Brand Name: Bisaf Strep A Self-Test. Test for detection recalled?
Product not cleared by the FDA.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model No. AL-42153; No UDI; Lot Code: 6952804827274.
- Product
- Brand Name: Bisaf Strep A Self-Test. Test for detection of group A streptococcal antigens in throat swabs.
- Recalling firm
- Altruan GmbH
- Quantity
- 188 units
- Distribution
- US Nationwide distribution.
- Recall date
- March 18, 2026
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)