FDA Device recall Z-2977-2020
Model No:T-SPOT.TB50, Catalogue No.: TB.50
- FDA Device
- Class III
- terminated
- Published 2020-09-23
On 2020-09-23 the FDA classified a Class III recall of Model No:T-SPOT.TB50, Catalogue No.: TB.50 by Oxford Immunotec, citing incorrect expiration date included in test kit labeling and/or in Substrate component label.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2977-2020 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2020-07-16 |
| Published | 2020-09-23 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Oxford Immunotec |
| Distribution | US |
Product
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.
Reason
Incorrect expiration date included in test kit labeling and/or in Substrate component label.
Identifiers
| code_info | Manufacturing Kit Lot Numbers: TFC2481752, TFC2621768, TFC2661790, TFC3081816, TFC3101817, TFC3111818, TFC3111825, TFC2621885, TFC2471883, TFC3361860. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2977-2020%22
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