RegWardenFDA facility compliance records
Company

COPAN ITALIA Spa

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

Recalls by year

FDA actions on record by year2013: 1 recalls; 2021: 1 recalls; 2025: 2 recalls1’13’14’15’16’17’18’19’201’21’22’23’242’25’26
  • Recalls (4)

Registered facilities (5)

Recalls & enforcement

  • Class IIOngoing2025-10-29
    Treatment reagent functionality in respiratory specimens liquification cannot be guaranteed.
  • Class IIOngoing2025-05-02
    Swabs for specimen collection may be prone to breakage during product usage.
  • Class IITerminated2021-07-09
    A sterility assurance level of 10-6 cannot be guaranteed due to intentional fraud and data integrity issues at the contract sterilizer, Steril Milano.
  • Class IIITerminated2013-08-09
    The recall of the WASP (Walk Away Specimen Process) instrument was initiated because Copan Italia SpA has upgraded the software concerning the broth inoculation table feature. The upgrade has been considered necessary from the manufacturer in order to eliminate the very low risk…

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. “COPAN ITALIA Spa — 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-9016900-copan-italia-spa/

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