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

FDA product code OJN · Class 3 · Unknown

7
Registered devices
0
Adverse events
5
Recalls
0
510(k) clearances

Devices with this code

T-Cell Select® — Oxford Immunotec, Inc.T.Cell Xtend® — Oxford Immunotec, Inc.T-SPOT®.TB96 — Oxford Immunotec, Inc.T.Cell Xtend® — Oxford Immunotec, Inc.T-Cell Select® — Oxford Immunotec, Inc.T-SPOT®.TB50 — Oxford Immunotec, Inc.T-SPOT®.TB8 — Oxford Immunotec, Inc.

Recent recalls

DateFirmReason
2022-07-07OXFORD IMMUNOTEC LTDDue 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 stora
2022-07-07OXFORD IMMUNOTEC LTDDue 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 stora
2022-07-07OXFORD IMMUNOTEC LTDDue 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 stora
2020-07-16Oxford ImmunotecIncorrect expiration date included in test kit labeling and/or in Substrate component label.
2020-07-16Oxford ImmunotecIncorrect expiration date included in test kit labeling and/or in Substrate component label.

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.