RegWardenFDA facility compliance records
Company

Menarini Silicon Biosystems Inc.

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

Recalls by year

FDA actions on record by year2018: 1 recalls; 2022: 1 recalls201712018201920202021120222023202420252026
  • Recalls (2)

Registered facilities (1)

Recalls & enforcement

  • Class IIOngoing2022-05-20
    High number of total images/unassigned events including (dual positives) and the potential for false positive results being placed into the image gallery in some patient samples
  • Class IITerminated2018-04-04
    Unusually high number of total images/unassigned events may require additional time and effort for the operator to review all the images and may cause a delay in reporting the 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. “Menarini Silicon Biosystems Inc. — 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-10054393-menarini-silicon-biosystems-inc/

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