T.Cell Xtend® TTK.610Recalls & reported problems

Oxford Immunotec, Inc. · Approval for the use of t-cell xtend reagent with the t-spot. Tb test, in order to extend the time from sample collection to sample processing from within 8 hours of venepuncture to between 23 and 30 hours post venepuncture; and to make a technical correction to the t-spot. Tb test package insert to change the number of blood collection tubes required from (2) 6 ml heparin tubes to (1) 6 ml heparin tube. The t-cell xtend reagent is indicated for use with the t-spot. Tb test for the pre-treatment of whole blood prior to lymphocyte separation. The reagent aids in the removal of selected white blood cells from whole blood stored at room temperature (18-25 degrees c). · 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-1642-2022 · Root cause: Storage · Recall details · FDA record ↗

Device details

UDI-DI	`15051716000022`
Brand	T.Cell Xtend®
Model	TTK.610
Catalog no.	TTK.610US
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): Cell centrifugation/density gradient separation reagent IVD

A substance or reactant intended to be used for the isolation of cells from a clinical specimen (e.g., lymphocytes from whole blood, cells from a liquid-based cytology specimen) using centrifugation and density gradient to achieve specimen component separation.

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

T-SPOT®.TB8 TB.300
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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