Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Cascade Abrazo cACTLR Test Card

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall Cascade Abrazo cACTLR Test Cardsee related information
Date Initiated by FirmFebruary 24, 2017
Create DateDecember 06, 2018
Recall Status1 Terminated 3 on October 20, 2023
Recall NumberZ-0561-2019
Recall Event ID 81378
Product Classification Hemoglobin m - Product Code JPB
ProductCascade 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
Code Information Lot Codes: 1-16-5701 Model/Catalog Number: 5701
FEI Number 1618982
Recalling Firm/
Manufacturer		 Helena Laboratories, Inc.
1530 Lindbergh Dr
Beaumont TX 77707-4131
For Additional Information ContactDr. Jessica Hanka
409-842-3714 Ext. 1177
Manufacturer Reason
for Recall		Due to some cards in this lot reported to have experienced variations in results, (verified by wave form), resulting in some cards with shorter or longer times than expected.
FDA Determined
Cause 2		Device Design
ActionOn 02/24/2017, the firm sent an email to affected users, with a Withdrawal Notification. The firm informed the customers/distributors that Due to some cards in this lot experiencing variations in wave form, resulting in some cards with shorter or longer times than expected. The firm instructed the customers/distributors to disposes of affected lot, as a preventive quality measure. On 04/12/2017, the firm mailed formal letters to all customers. PUBLIC CONTACT: "Name: Dr. Jessica Jones Hanka "Title: Technical Services Manager "Address: 1530 Lindbergh Drive, Beaumont, TX 77707 "Telephone #: (409) 842-3714 x1177 "Email: jhanka@helena.com
Quantity in Commerce27 kits
DistributionUS: Products under control of Manufacturer in TX OUS: Four International Distributors - Australia, Netherlands, Italy, and England
Total Product Life CycleTPLC 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.
-
-