Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Clearest Strep-A Cassette Test. Test to determine the presence of Recalled by Altruan GmbH Due to Product not cleared by the FDA.
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Altruan GmbH directly.
Affected Products
Clearest Strep-A Cassette Test. Test to determine the presence of group A streptococci (Strep A) in throat swab samples.
Quantity: 188 units
Why Was This Recalled?
Product not cleared by the FDA.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Altruan GmbH
Altruan GmbH has 3 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report