Facility

OXFORD IMMUNOTEC LTD

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

Key facts

2recalls · 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)	3015492990
Establishment type	Manufacture Medical Device
Location	143 Park Drive East Abingdon Oxfordshire, GB OX14 4SE
Registration status	Active · expires 2026
Parent company	Oxford Immunotec Ltd (owner-operator 10026700)

Activity by year

Recalls (2)

Devices registered here (1)

Culture Media, Enriched
Product code KZI (opens in a new tab) · Class I · Microbiology · 21 CFR 866.2330

Recalls & enforcement

Class IIOngoing2022-07-07
Due to equipment failure, affected products were stored at temperatures outside the validated range of 2-8 degree C for a period longer than the validated storage time.
Class IIITerminated2020-07-16
Incorrect expiration date included in test kit labeling and/or in Substrate component label.

All facilities operated by Oxford Immunotec Ltd

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. “OXFORD IMMUNOTEC LTD (FEI 3015492990) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3015492990-oxford-immunotec-ltd/

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