Facility

Fujirebio Diagnostics, Inc.

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

Key facts

1recalls · worst Class II

1inspections · worst NAI

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	1643621
Establishment type	Manufacture Medical Device for Another Party (Contract Manufacturer)
Location	940 Crossroads Blvd Seguin, TX, US 78155
Registration status	Active · expires 2026
Parent company	Fujirebio Diagnostics, Inc. (owner-operator 10022860)
Brand names	ARCHITECT Cyclosporine Whole Blood Precipitation Reagent; Transplant Pretreatment Tubes 1P06; ARCHITECT Cyclosporine Calibrators; ARCHITECT Cyclosporine; Alinity i Cyclosporine Calibrators; Alinity i Cyclosporine Reagent; Alinity i Cyclosporine Whole Blood Precipitation Reagent

Activity by year

Recalls (1)
Inspections (1)

Devices registered here (2)

Calibrators, Drug Specific
Product code DLJ (opens in a new tab) · Class II · Clinical Toxicology · 21 CFR 862.3200
Cyclosporine
Product code MKW (opens in a new tab) · Class II · Clinical Chemistry · 21 CFR 862.1235

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…

FDA inspections (1)

NAI2016-05-19
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

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 Diagnostics, Inc. (FEI 1643621) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1643621-fujirebio-diagnostics-inc/

Not open yet

Alerts for Fujirebio Diagnostics, Inc.

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.