RegWardenFDA facility compliance records
Company

DiaSorin Molecular LLC

5 recall(s) on record — most severe on record: Class II.

Recalls by year

FDA actions on record by year2020: 1 recalls; 2021: 2 recalls; 2023: 2 recalls2017201820191202022021202222023202420252026
  • Recalls (5)

Registered facilities (1)

Recalls & enforcement

  • Class IIOngoing2023-06-14
    There is a potential for the direct amplification disc to malfunction which may result in spillage of liquid from the disc.
  • Class IIOngoing2023-01-30
    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.
  • Class IIOngoing2021-11-19
    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…
  • Class IIOngoing2021-09-23
    Due to unapproved raw materials used in the manufacturing of Covid-19 control pack, their is the potential for delayed amplification signals.
  • Class IITerminated2020-05-12
    Due to a software malfunction in the Multi Assay Suite, there is the probability of increased occurrence of false negative results.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “DiaSorin Molecular LLC — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-9089763-diasorin-molecular-llc/

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