Diasorin Molecular Llc

There is a potential for the direct amplification disc to malfunction which may result in spillage of liquid from the disc.

Direct amplification Discs , used with COVID-19 and Flu A/B & RSV assays, may leak and cause contamination, cross-contamination, invalid results, and error codes.

Direct amplification Discs , used with COVID-19 and Flu A/B & RSV assays, may leak and cause contamination, cross-contamination, invalid results, and error codes.

Due to a software malfunction in the Multi Assay Suite, there is the probability of increased occurrence of false negative results.

Due to a software malfunction in the Multi Assay Suite, there is the probability of increased occurrence of false negative results.

Due to a software malfunction in the Multi Assay Suite, there is the probability of increased occurrence of false negative results.

Due to unapproved raw materials used in the manufacturing of Covid-19 control pack, their is the potential for delayed amplification signals.

A subset of affected discs are at risk of leakage when it is used more than one time with Simplexa COVID-19 Direct and/or Simplexa Flu A/B & RSV Direct Gen II. Leakage from a well that had a positive sample may cause further cross-contamination in areas of the lab if not properly cleaned.