Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Status Flu A + B Test Manufactured by Princeton Bio Recalled by Princeton Biomeditech Corp Due to There have been reports of dual positive (Flu...
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 Princeton Biomeditech Corp directly.
Affected Products
Status Flu A + B Test Manufactured by Princeton Bio Meditech Corporation Monmouth Junction, NJ 08852 USA. The BioSign Flu A + B test is an in vitro rapid qualitative test that detects influenza type A and type B nucleoprotein antigens directly from nasal swab, nasopharyngeal swab and nasal pharyngeal aspirate/wash specimens obtained from patients with signs and symptoms of respiratory infection. It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections. A negative test result is presumptive and it recommended that these results be confirmed by viral culture. Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other management decisions. The test is intended for professional and laboratory use.
Quantity: 90 kits (22 tests per kit)
Why Was This Recalled?
There have been reports of dual positive (Flu A + Flu B positive) results being encountered.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Princeton Biomeditech Corp
Princeton Biomeditech Corp has 4 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report