Class 2 Device Recall ELAntiSARSCoV2 IgG Kit

• Date Initiated by Firm: October 05, 2020
• Create Date: August 27, 2021
• Recall Status: Terminated on February 15, 2022
• Recall Number: Z-2382-2021
• Recall Event ID: 88478
• Product Classification: Reagent, coronavirus serological - Product Code QKO
• Product: EL-Anti-SARS-CoV-2 IgG Kit, Catalog #104-130. Submitted as EUA202128
• Code Information: Lot numbers 05204351, exp. 5/1/2021, and 05204368, exp. 05/19/2021.
• Recalling Firm/ Manufacturer: Thera Test Laboratories, Inc.; 1120 N Du Page Ave; Lombard IL 60148-1247
• For Additional Information Contact: Mr. Anthony Tate; 630-627-6069 Ext. 241
• Manufacturer Reason for Recall: The cross-reactivity of the device may present an increased level of potential false positives. Submitted as EUA202128
• FDA Determined Cause: No Marketing Application
• Action: The firm initiated the recall using undated letters attached to emails sent on 10/7/2020 requesting return of product.
• Quantity in Commerce: 19 kits
• Distribution: US Nationwide distribution in the states of California, Florida, Illinois, Indiana, North Carolina, and Texas.
• 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.