Bisaf Strep A self-test recalled because it lacks FDA clearance
Altruan GmbH is recalling the Bisaf Strep A Self-Test, used to detect group A streptococcal antigens in throat swabs, because the product is not cleared by the FDA.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Rubric level 2 covers voluntary precautionary recalls: the recall is for a missing regulatory clearance and the source describes no defect, malfunction or hazard in the product.
Plain-English summary
Altruan GmbH is recalling the Bisaf Strep A Self-Test, a test for detection of group A streptococcal antigens in throat swabs. About 188 units were distributed nationwide in the United States. The FDA has classified this recall as Class II.
The product is not cleared by the FDA. The source record does not describe a defect, malfunction or hazard in the test itself.
Affected product is model AL-42153, lot code 6952804827274. The product carries no UDI.
Users can identify affected tests by the model and lot code above, and may contact Altruan GmbH for further information.
The recalled product
- Product
- Brand Name: Bisaf Strep A Self-Test. Test for detection of group A streptococcal antigens in throat swabs.
- Manufacturer
- Altruan GmbH
- Category
- Medical Device — Diagnostic test
- Hazard
- missing-clearance
- regulatory-recall
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Model No. AL-42153
- No UDI
- Lot Code: 6952804827274.
Distribution
Distributed nationwide across the United States.
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