FDAFebruary 10, 2016device

Simplexa Group A Strep Direct (MOL2850) with Direct Amplification Disc (MOL1451, MOL1452, MOL1455) Model Number: MOL2850, MOL1451, MOL1452, MOL1455

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Terminated

Brands named

focus diagnosticsfocus

UPCs

22654812258543

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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