Facility

ORTHO-CLINICAL DIAGNOSTICS, INC.

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

Key facts

1recalls · worst Class II

1inspections · worst VAI

—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)	1000305841
Establishment type	Manufacture Medical Device
Location	1000 LEE RD. Rochester, NY, US 14606
Registration status	Active · expires 2026
Parent company	QuidelOrtho Corporation (owner-operator 2024674)
Brand names	VITROS TIBC Kit; VITROS Calibrator Kit 4

Activity by year

Recalls (1)
Inspections (1)

Devices registered here (2)

Ferrozine (Colorimetric) Iron Binding Capacity
Product code JMO (opens in a new tab) · Class I · Clinical Chemistry · 21 CFR 862.1415
Calibrator, Secondary
Product code JIT (opens in a new tab) · Class II · Clinical Chemistry · 21 CFR 862.1150

Recalls & enforcement

Class IIOngoing2024-04-09
T3 Reagent Packs used with Free T3 Calibrators may produce positively biased results for patient and quality control samples. The positive bias may cause erroneous patient results or a delay in testing that may impact patient management, clinical assessment, and the results of ot…

FDA inspections (1)

VAI2017-03-31
Voluntary Action Indicated · Compliance: Devices · citations posted

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. “ORTHO-CLINICAL DIAGNOSTICS, INC. (FEI 1000305841) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1000305841-ortho-clinical-diagnostics-inc/

Not open yet

Alerts for ORTHO-CLINICAL 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.