Simplexa Direct Amplification Disc Kit

A recent internal investigation revealed that a subset of Simplexa Direct Amplification Discs (Ref MOL1455) are at risk of leakage when the disc is used more than one time with Simplexa Covid-19 direct and/or Simplexa flu A/B & RSV Direct Gen II. The predicted risk of leakage has been determined to be very low (0.0045%) Recall start date: Nov 19, 2021

Lack of efficacy

Simplexa Direct Amplification Disc Kit

RA-63711