medical Class III Updated 2020-09-23

Oxford Immunotec recalls Model No:T-SPOT.TB50, Catalogue No.: TB.50; UDI: 15051716000

Recalled 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.


Hazard / Issue

Incorrect expiration date included in test kit labeling and/or in Substrate component label.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Manufacturing Kit Lot Numbers: TFC2481752, TFC2621768, TFC2661790, TFC3081816, TFC3101817, TFC3111818, TFC3111825, TFC2621885, TFC2471883, TFC3361860.
View official government recall

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