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U.S. Department of Health and Human Services

Class 2 Device Recall KACT

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  Class 2 Device Recall KACT see related information
Date Initiated by Firm November 09, 2020
Create Date December 17, 2020
Recall Status1 Open3, Classified
Recall Number Z-0635-2021
Recall Event ID 86774
510(K)Number K061014  K013078  
Product Classification System, multipurpose for in vitro coagulation studies - Product Code JPA
Product K-ACT Actalyke Clotting Test Tubes that are used in the: ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, and ACTALYKE MINI ACTIVATED CLOTTING TIME TEST SYSTEM.
Code Information Catalog Number: K-ACT Lot Number: 1-19-K-ACT and 2-19-K-ACT 
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		 Due to complaints received associated with cracked/split test tube caps.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action On 11/09/2020, international distributors were initially contacted and provided with a notification for distributors letter. On 11/16/2020 domestic customers were contacted via telephone and then a formal notification was delivered. The Recalling Firm was informing its customers to the potential of defect associated with the (flip-top) caps for some test tubes where the cap my split resulting in leaking of biohazardous fluids as users are instructed to shake the tube for proper mixing. Customers are instructed to immediately examine their inventory and quarantine affected product. If customers have further distributed the affected product, they are asked to identify the users within their facility to notify them at once of this product recall. Customers are also asked to complete and return the response form as soon as possible. For any questions, customer can email or call the Recalling Firm as jhanka@Helena.com or 1-800-231-5663 extension 1177.
Quantity in Commerce Lot 1-19-K-ACT = 314 tubes and Lot 2-19-K-ACT = 297 tubes
Distribution Worldwide distribution - U.S. Nationwide including in the states of NJ, NY, PA and TX. The countries of Austria, Canada, England, France, Italy, Portugal, Russia, Spain.
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.
510(K) Database 510(K)s with Product Code = JPA and Original Applicant = HELENA LABORATORIES
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