Class 2 Device Recall Cascade Abrazo aPTT Test Card

• Date Initiated by Firm: December 07, 2017
• Date Posted: September 27, 2019
• Recall Status: Terminated on June 09, 2020
• Recall Number: Z-2761-2019
• Recall Event ID: 83629
• Product Classification: Activated partial thromboplastin - Product Code GFO
• Product: Cascade Abrazo aPTT Test Card, Model 5722, For Export Only. The firm name on the label is Helena Laboratories, Beaumont, TX.
• Code Information: Lot number 2-17-5722, Exp. 2018-09-30
• FEI Number: 1618982
• Recalling Firm/ Manufacturer: Helena Laboratories, Corp.; 1530 Lindbergh Dr; Beaumont TX 77707-4131
• For Additional Information Contact: Dr. Jessica Jones Hanka; 409-842-3714
• Manufacturer Reason for Recall: Some of the cards show occasional shorter clot times than the expected variation resulting in a potential false negative result on the screening assay.
• FDA Determined Cause: Unknown/Undetermined by firm
• Action: The recalling firm issued letters dated 11/12/2017 via email on 12/7/2017 explaining the issue and that they were doing a withdrawal of the lot.
• Quantity in Commerce: 21 kits
• Distribution: Distribution was made to Germany and Australia. There was no U.S. distribution.
• 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.