RegWardenFDA facility compliance records
Facility

Fujirebio Inc. Ube Facility

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

Activity by year

FDA actions on record by year2025: 1 recalls20172018201920202021202220232024120252026
  • Recalls (1)

Devices registered here (3)

  • Calibrator, Secondary
    Product code JIT (opens in a new tab) · Class II · Clinical Chemistry · 21 CFR 862.1150
  • Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
    Product code JJE (opens in a new tab) · Class I · Clinical Chemistry · 21 CFR 862.2160
  • Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)
    Product code LTK (opens in a new tab) · Class II · Immunology · 21 CFR 866.6010

Recalls & enforcement

  • Class IIOngoing2025-12-11
    Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low specificity when compared back to FDA-cleared CSF ratio/PET imaging, due to falsely elevated positive ratio or falsely elevated ind…

Related

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Fujirebio Inc. Ube Facility (FEI 3014643041) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3014643041-fujirebio-inc-ube-facility/

Not open yet

Alerts for Fujirebio Inc. Ube Facility

Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.

Planned

Want a one-page facility brief?

A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.