Class 2 Device Recall Epitope Diagnostics, Inc. Novel Coronavirus COVID19 IgG ELISA Kit, REF: KT1032

• Date Initiated by Firm: October 01, 2020
• Create Date: November 06, 2020
• Recall Status: Open, Classified
• Recall Number: Z-0426-2021
• Recall Event ID: 86516
• Product Classification: Reagent, coronavirus serological - Product Code QKO
• Product: EDI Novel Coronavirus COVID-19 IgG ELISA Kit, REF: KT-1032; ; Per label: This kit is intended for qualitative detection of human anti-COVID-19 IgG antibody in human serum. This kit is to be used as an aid for the detection of novel COVID-19. Patients with suspected clustering cases require diagnosis or differential diagnosis of novel coronavirus infection.
• Code Information: Lot Numbers: P826, P815, P796, P776
• Recalling Firm/ Manufacturer: Epitope Diagnostics, Inc.; 7110 Carroll Rd; San Diego CA 92121-2215
• For Additional Information Contact: 858-693-7877
• Manufacturer Reason for Recall: The use of deionized water rather than distilled water during the manufacturing process, may have resulted in accelerated decreased OD signals for the Positive Control value.
• FDA Determined Cause: Nonconforming Material/Component
• Action: On 10/01/20, the firm, Epitope Diagnostics Inc. (EDI), sent "URGENT: EDI" Novel Coronavirus COVID-19 IgG ELISA Kit Recall" notices were sent to customers. Customers were asked to do the following: Results where the assay controls do not meet the manufacturer's defined specifications should be considered invalid and repeated with another lot. Immediately examine your inventory and quarantine product subject to recall. In addition, if you have further distributed this product, please identify your customers and notify them at once of this product recall. Complete and promptly return the Customer Response Form by Email to: cs@epitopediagnostics.com or Fax to: 858-693-7877. Your notification to your customers may be enhanced by including a copy of this recall notification letter. For customers located within United States, we will ask that you return this affected product to the recalling firm. For customers located outside United States, please destroy the affected product. For any questions, please refer to EDIs Quality Assurance and Regulatory Affairs Manager, Stefanie Dallezotte, by email: lenart@epitopediagnostics.com or by telephone: +1 858 693 7877.
• Quantity in Commerce: 2886
• Distribution: U.S Distribution.: NH, CO, OR, CA, FL, NY, MD, NJ, IL, NC, MI, TX, PA, MA, OH, NM, VA, SC, HI, and TN.
• 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.