Class III — Oxford Immunotec
| Recalling firm | Oxford Immunotec Ltd |
|---|---|
| Registered facility | OXFORD IMMUNOTEC LTD (the firm's only registered facility) |
| Classification | Class III |
| Status | Terminated |
| Reason | Incorrect expiration date included in test kit labeling and/or in Substrate component label. |
| 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. |
| Quantity | 125 units |
| Distribution | Worldwide distribution - U.S. Nationwide distribution including in the states of AL, CO, D.C., GA, ID, IN, MD, OH, PA, TN, TX, and VA. The countries of Austria, Belgium, Czech Republic, France, Germany, Italy, Kuwait, Latvia, Netherlands, Philippines, Saudi Arabia, Singapore, South Korea, Spain, Sweden, Switzerland, Turkey, United Kingdom. |
| Initiated | 2020-07-16 |
| Classified | 2020-09-16 |
| Terminated | 2021-09-13 |
| Recall number | Z-2977-2020 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class III recall — Oxford Immunotec (Z-2977-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/86003/
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