DiaSorin Molecular Simplexa Direct Amplification Disc Kit, Rx Only, IVD The Simplexa Direct recall — FDA Z-2153-2023
There is a potential for the direct amplification disc to malfunction which may result in spillage of liquid from the disc.
Overview of recall records associated with DiaSorin Molecular LLC, including dates, categories and classifications where available.
Classification mix: Class II: 8.
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.
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…
Due to unapproved raw materials used in the manufacturing of Covid-19 control pack, their is the potential for delayed amplification signals.
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.
This page summarizes recall records in which the official source identifies DiaSorin Molecular LLC as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.