Home › Oxford Immunotec, Inc. › T-SPOT®.TB50
T-SPOT®.TB50
Oxford Immunotec, Inc. · Model TB.50 · UDI-DI 15051716000046
0
510(k) clearances
0
Adverse events
5
Recalls
1
Facilities
Description
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 assessment, radiography and other medical diagnostic evaluations.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-07-07 | OXFORD IMMUNOTEC LTD | 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. |
| 2022-07-07 | OXFORD IMMUNOTEC LTD | 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. |
| 2022-07-07 | OXFORD IMMUNOTEC LTD | 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. |
| 2020-07-16 | Oxford Immunotec | Incorrect expiration date included in test kit labeling and/or in Substrate component label. |
| 2020-07-16 | Oxford Immunotec | Incorrect expiration date included in test kit labeling and/or in Substrate component label. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.