RegWardenFDA facility compliance records
Company

ASSOCIATES OF CAPE COD, 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 IITerminated2022-08-17
    Incorrect information on the Fungitell STAT clamshells containing the Fungitell STAT Standard, relates to printed information for reconstitution and pretreatment volumes
  • Class IITerminated2018-12-19
    The kits may contain the incorrect number of components or the kits may be missing components.

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. “ASSOCIATES OF CAPE COD, 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-1219145-associates-of-cape-cod-inc/

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