Class 2 Device Recall Cascade Abrazo cACTLR Test Card

• Date Initiated by Firm: April 20, 2016
• Create Date: December 10, 2018
• Recall Status: Terminated on February 15, 2024
• Recall Number: Z-0594-2019
• Recall Event ID: 81356
• Product Classification: Hemoglobin m - Product Code JPB
• Product: Cascade Abrazo c-ACT-LR Test Card IVD FOR IN VITRO DIAGNOSTIC USE Store at 2 to 8 C HELENA LABORATORIES 003366 12/13(2) FOR EXPORT ONLY The Cascade Abrazo c-ACT-LR test cards are activated clotting time tests to be used with the Cascade Abrazo analyzer and are intended to monitor the effect of low to moderate heparin on coagulation in fresh whole blood.
• Code Information: Lot Codes: 1-15-5701 Model/Catalog Number: 5701
• FEI Number: 1618982
• Recalling Firm/ Manufacturer: Helena Laboratories, Inc.; 1530 Lindbergh Dr; Beaumont TX 77707-4131
• For Additional Information Contact: Dr. Jessica Hanka; 409-842-3714 Ext. 1177
• Manufacturer Reason for Recall: Due to some cards in this lot experiencing variations in wave form, resulting in some cards with shorter or longer times than expected
• FDA Determined Cause: Device Design
• Action: On 04/20/2016 the firm, Helena Laboratories, contacted affected users via email, and then sent a "WITHDRAWAL NOTIFICATION" (dated April 25, 2016) on 04/27/2016. The notification described the product, problem and actions to be taken. The firm instructed the customers/distributors to disposes of affected lot, as a preventive quality measure. The Withdrawal Notification for Removal of Product from Inventory stated, This lot is to be handled by Distributors, as follows: ___ Prevent any shipments or scheduled demonstrations with this lot ___ Remove this lot from Available Inventory and discard the cards ___ Place cards in Quarantine  pending disposal ___ Contact International Sales for credit and delivery of replacement cards Verify amount REMOVED FROM STOCK: Total number pulled: ____________________ Date _____________________________ The following signifies written certification that this lot has not been sent to an end user: Verified by: _____________________________________________________________ Please complete this form and return a copy to Helena Laboratories, via: FAX: 409-842-1874 or e-mail to jjones@helena.com  For questions, contact  Mgr., Technical Services at: 1 (409) 842-3714 ext. 1177. *Reason for removal: Some cards in this lot are experiencing variations in wave form, resulting in possible shorter, or longer, times than expected. While this issue, if present, should be found via use of the Quality Control materials, due to its intermittent nature in the cards, this alone cannot be relied upon.
• Quantity in Commerce: 12 Kits
• Distribution: US Distribution to state of TX and internationally to: Australia, Netherlands, Italy, and England.
• 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.