Class 2 Device Recall Cascade Abrazo aPTT Test Card

• Date Initiated by Firm: January 05, 2021
• Create Date: February 11, 2021
• Recall Status: Open, Classified
• Recall Number: Z-1108-2021
• Recall Event ID: 87151
• Product Classification: Activated partial thromboplastin - Product Code GFO
• Product: Cascade Abrazo aPTT Test Card - Product Usage: are to be used with the Cascade Abrazo analyzer and are intended for the determination of the activated Partial Thromboplastin Time (aPTT) of citrated whole blood or plasma, Model 5722, For Export Only.
• Code Information: Model Number: 5722 Lot Numbers: 1-20-5722 expiration date 90/30/2021; 3-20-5722 expiration date 11/30/2021; 4-20-5722 expiration date 12/31/2021
• Recalling Firm/ Manufacturer: Helena Laboratories, Corp.; 1530 Lindbergh Dr; Beaumont TX 77707-4131
• For Additional Information Contact: Dr. Jessica Jones Hanka; 409-842-3714 Ext. 1177
• Manufacturer Reason for Recall: Intermittent potential for shorter than expected clot times.
• FDA Determined Cause: Under Investigation by firm
• Action: On 01/05/2021, the firm sent an "URGENT MEDICAL DEVICE RECALL" Notification Letter via email to it distributors informing them that this Recall has been identified due to the potential for shorter than expected clot times on abnormal patients and on abnormal controls on some cards from specific lots and the use of these products may include difficulty achieving abnormal control results in range and incorrectly low patient results. Distributors were instructed to: 1) Immediately examine their inventory and quarantine the specific product lots 2) If they have further distributed the affected product, they are to identify these customers and notify them at once. In addition, the notification to their customers may be enhanced by including a copy of the recall notification letter, which must include instruction of what customers should do with the recalled product. 3) Complete and return enclosed response form as soon as possible Any questions, email or contact Dr. Jessica Jones Hanka at jhanka@helena.com or 1-800-231-5663 ext. 1177. Distributors were contacted by email and requested to evaluate inventory while the Recalling Firm investigated issue . Distributors were formally notified of recall on 1/5/2021 and provided with a template for a notification letter to translate and send to end users in each country. End users will be asked to return unused product to the distributor, and distributors will forward all returned product to Helena Labs. Distributors will be asked to provide an account of all product distributed. Effectiveness will be determined by evaluating the total product returned and the total product accounted for based on information provided by distributors.
• Quantity in Commerce: 205 total kits
• Distribution: Worldwide distribution - U.S. Nationwide distribution and the countries of Germany, Italy, Romania, Australia, Chile.
• 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.