RegWardenFDA facility compliance records
Company

KAMIYA BIOMEDICAL COMPANY LLC

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

Recalls by year

FDA actions on record by year2017: 1 recalls; 2022: 1 recalls120172018201920202021120222023202420252026
  • Recalls (2)

Registered facilities (1)

Recalls & enforcement

  • Class IIOngoing2022-09-28
    IgA Reagent may start showing cloudiness over time, which can affect assay performance.
  • Class IITerminated2017-07-19
    The AlAT calibrator values in the package insert for the Multi-Analyte Calibrator, lot D755, lots N653 and lot N654 were not correct.

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. “KAMIYA BIOMEDICAL COMPANY 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-9001370-kamiya-biomedical-company-llc/

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