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U.S. Department of Health and Human Services

Class 2 Device Recall Cascade Abrazo aPTT Test Card

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  Class 2 Device Recall Cascade Abrazo aPTT Test Card see related information
Date Initiated by Firm December 07, 2017
Date Posted September 27, 2019
Recall Status1 Terminated 3 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
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 2		 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.
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