Facility

Ortho-Clinical Diagnostics

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)	3007111389
Establishment type	Manufacture Medical Device
Location	Felindre Meadows Pencoed Bridgend, GB CF35 5PZ
Registration status	Active · expires 2026
Parent company	QuidelOrtho Corporation (owner-operator 2024674)
Brand names	VITROS Anti-SARS-CoV-2 IgG Calibrator; VITROS Anti-SARS-CoV-2 IgG Reagent Pack; VITROS Anti-SARS-CoV-2 IgG Controls

Activity by year

Recalls (1)
Inspections (1)

Devices registered here (1)

Sars-Cov-2 Serology Test
Product code QVP (opens in a new tab) · Class II · Microbiology · 21 CFR 866.3983

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)

NAI2018-02-01
No Action Indicated · Compliance: 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. “Ortho-Clinical Diagnostics (FEI 3007111389) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3007111389-ortho-clinical-diagnostics/

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