Oxford Immunotec Ltd
Abingdon Oxfordshire, GB
OXFORD IMMUNOTEC LTD appears in FDA device records in Abingdon Oxfordshire, GB. FDA records list no 510(k) clearances, 28 PMA records and one registered establishment. As of , FDA records show 5 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
No 510(k) clearance records for this company in the ingested FDA data.
No 510(k) clearance records in the ingested FDA data.
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3015492990 | 3015492990 | OXFORD IMMUNOTEC LTD | 143 Park Drive East, Abingdon Oxfordshire OX14 4SE GB | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1643-2022 | AIM-V Medium REF AV.200/500 | 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 II | Open, Classified | |
| Z-1642-2022 | T-Cell Xtend REF TTK.610 US | 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 II | Open, Classified | |
| Z-1641-2022 | T-SPOT.TB REF TB.300 US | 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 II | Open, Classified | |
| Z-2977-2020 | Model No:T-SPOT.TB50, Catalogue No.: TB.50; UDI: 1505171600004 - Product Usage: intended for use as an aid in the diagnosis of Mycobacterium tuberculosis infection by detecting effector T cells that respond to stimulation by M. tuberculosis antigens ESAT-6 and CFP10, and capturing interferon-gamma in the vicinity of these cells. | Incorrect expiration date included in test kit labeling and/or in Substrate component label. | Class III | Terminated | |
| Z-2976-2020 | Model No:T-SPOT.TB8, Catalogue No.: TB.300; UDI: 1505171600030 - Product Usage: intended for use as an aid in the diagnosis of Mycobacterium tuberculosis infection by detecting effector T cells that respond to stimulation by M. tuberculosis antigens ESAT-6 and CFP10, and capturing interferon-gamma in the vicinity of these cells. | Incorrect expiration date included in test kit labeling and/or in Substrate component label. | Class III | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain