Z-2977-2020 Class III Terminated
FDA device recall Z-2977-2020 was initiated by Oxford Immunotec on July 16, 2020 and is designated Class III. Reason for recall: Incorrect expiration date included in test kit labeling and/or in Substrate component label. The recall status is terminated (terminated September 13, 2021). Affected quantity: 125 units.
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
- 125 units
Product Description
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 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: TFC2481752, TFC2621768, TFC2661790, TFC3081816, TFC3101817, TFC3111818, TFC3111825, TFC2621885, TFC2471883, TFC3361860.