Facility

ORTHO-CLINICAL DIAGNOSTICS, INC.

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

Key facts

1recalls · worst Class II

—inspections in our data

—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)	2250051
Establishment type	Complaint File Establishment per 21 CFR 820.198
Location	1001 US Highway 202 RARITAN, NJ, US 08869
Registration status	Active · expires 2026
Parent company	QuidelOrtho Corporation (owner-operator 2024674)
Brand names	VITROS C3 Reagent; VITROS C4 Reagent

Activity by year

Recalls (1)

Devices registered here (4)

Complement C4, Antigen, Antiserum, Control
Product code DBI (opens in a new tab) · Class II · Immunology · 21 CFR 866.5240
Single (Specified) Analyte Controls (Assayed And Unassayed)
Product code JJX (opens in a new tab) · Class I · Clinical Chemistry · 21 CFR 862.1660
Calibrator, Secondary
Product code JIT (opens in a new tab) · Class II · Clinical Chemistry · 21 CFR 862.1150
Complement C3, Antigen, Antiserum, Control
Product code CZW (opens in a new tab) · Class II · Immunology · 21 CFR 866.5240

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…

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 2250051) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/2250051-ortho-clinical-diagnostics-inc/

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