Class 3 Device Recall TSPOT.TB

• Date Initiated by Firm: July 16, 2020
• Create Date: September 16, 2020
• Recall Status: Terminated on September 13, 2021
• Recall Number: Z-2976-2020
• Recall Event ID: 86003
• Product Classification: Mycobacterium tuberculosis, Cell mediated immune response, enzyme-linked immunospot test - Product Code OJN
• Product: 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.
• Code Information: Manufacturing Kit Lot Numbers: TEC3321847, TEC3041811.
• Recalling Firm/ Manufacturer: Oxford Immunotec; 94C Innovation Drive; Milton Park; Abingdon United Kingdom
• Manufacturer Reason for Recall: Incorrect expiration date included in test kit labeling and/or in Substrate component label.
• FDA Determined Cause: Labeling False and Misleading
• Action: The recall letters were sent to consignees on July 16, 2020 and sent via certified mail (return receipt). Actions to be taken by the Customer/User: Locate the product in possession, and any in central supply departments, and note the quantity remaining on the verification form attached to this notification. Return the completed form following the instructions below. Then collection of the remaining product will be arranged and shipment of the replacement product. If there has been further distribution of the affected lot number also forward the notification to the appropriate end users. NOTE: NO OTHER LOTS OR PRODUCTS ARE INVOLVED IN THIS RECALL.. There is an enclosed verification form to acknowledge that the recall notice has been received and to document the quantity remaining in stock for return and replacement. Complete the form immediately indicating one of the following options: - There is no remaining stock of the aforementioned kit lots. - There is stock of the aforementioned kit lots remaining in inventory. Record the quantity of stock remaining for replacement. The verification form should be sent via email to Ben Hamilton at bhamilton@oxfordimmunotec.com, even if there is no product remaining in inventory. The completed form should also be returned using a prepaid enclosed envelope . Upon receipt of the completed and returned verification form, there will be contact to arrange courier collection of any remaining stock, and be provided information as to when replacement stock will be shipped. Other Information: For questions regarding this voluntary recall notification, or would like assistance with this recall, call: - Ben Hamilton at +44 1235 442619, Monday through Friday, 8 am to 12 pm Eastern Time - Alternatively, call the toll-free number at 1-877-208-7768, Monday through Friday, 8 am to 12 pm Eastern Time. Following the automated instructions, dial 4 to go through to the name directory and request Ben Hamilton. If no one is available t
• Quantity in Commerce: 583 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.