Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Simplexa Flu A/B & RSV Direct (MOL2650) with Direct Amplification Disc (MOL1451 Recalled by Focus Diagnostics Inc Due to Focus Diagnostics is recalling the Direct Amplification Discs...
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 Focus Diagnostics Inc directly.
Affected Products
Simplexa Flu A/B & RSV Direct (MOL2650) with Direct Amplification Disc (MOL1451, MOL1452, MOL1455) Model Number: MOL2650, MOL1451, MOL1452, MOL1455
Quantity: 7421 units
Why Was This Recalled?
Focus Diagnostics is recalling the Direct Amplification Discs (DAD) supplied with the Simplexa HSV 1 & 2 Direct (MOL2150), Simplexa Flu A/B & RSV Direct (MOL2650) and Simplexa Group A Strep Direct kits (MOL2850) because it may result in a false negative result, a false positive result or Error code (s) 500 or 505, and it may result in higher invalid rates.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Focus Diagnostics Inc
Focus Diagnostics Inc has 11 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report