T-SPOT®.TB8 TB.300Recalls & reported problems

Oxford Immunotec, Inc. · For the detection of effector t cells that respond to stimulation by mycobacterium tuberculosis antigens esat-6 and cfp-10 and indicated for use as an aid in the diagnosis of m.Tuberculosis infection in conjunction with risk assesment, radiography and other medical diagnostic evaluations. · Class 3

Data updated Oct 18, 2026 from official FDA records · Editorial policy

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports: 0
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 1

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

Jul 7, 2022Class IIOpen, Classified
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.
Z-1641-2022 · Root cause: Storage · Recall details · FDA record ↗

Device details

UDI-DI	`15051716000305`
Brand	T-SPOT®.TB8
Model	TB.300
Catalog no.	TB.300US
Company	Oxford Immunotec, Inc.
Product code	OJN · Mycobacterium Tuberculosis, Cell Mediated Immune Response, Enzyme-Linked Immunospot Test
Class	Class 3
FDA submission	P070006
Implant	No
Rx / OTC	—
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Jul 6, 2018

Device type (GMDN): Mycobacterium tuberculosis complex species antigen IVD, kit, enzyme immunoassay (EIA)

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antigens from bacterial species of the Mycobacterium tuberculosis complex (M. tuberculosis, M. bovis, M. bovis Bacillus Calmette-Guerin, M. africanum, M. canetti, M. microti, M. caprae and M. pinnipedi) in a clinical specimen and/or culture isolate, using an enzyme immunoassay (EIA) method.

Other Mycobacterium Tuberculosis, Cell Mediated Immune Response, Enzyme-Linked Immunospot Test devices

T.Cell Xtend® TTK.610
Oxford Immunotec, Inc. · Mycobacterium Tuberculosis, Cell Mediated Immune Response, Enzyme-Linked Immunospot Test
1 recall0 reports

All Mycobacterium Tuberculosis, Cell Mediated Immune Response, Enzyme-Linked Immunospot Test devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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