Home / Recalls / Oxford Immunotec / Z-2976-2020

Z-2976-2020 Class III Terminated

Recalled by Oxford Immunotec — Abingdon, N/A

Recall Details

Product Type: Devices
Report Date: September 23, 2020
Initiation Date: July 16, 2020
Termination Date: September 13, 2021
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 583 units

Product Description

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.

Reason for Recall

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

Distribution Pattern

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.

Code Information

Manufacturing Kit Lot Numbers: TEC3321847, TEC3041811.