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U.S. Department of Health and Human Services

Class 2 Device Recall SPIFE ImmunoFix6 Kit

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  Class 2 Device Recall SPIFE ImmunoFix6 Kit see related information
Date Initiated by Firm July 21, 2017
Create Date October 04, 2019
Recall Status1 Terminated 3 on June 19, 2020
Recall Number Z-0045-2020
Recall Event ID 83622
510(K)Number K973040  
Product Classification Immunoelectrophoretic, immunoglobulins, (g, a, m) - Product Code CFF
Product SPIFE ImmunoFix-6 Kit, Cat. No. 3401, 3401T, For In-Vitro Diagnostic Use. The firm name on the label is Helena Laboratories, Beaumont, TX.
Code Information Lot 35-17-552583, exp. date 4/30/2018
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		 The plates do not have wells punched for the controls in the patient 1 area.
FDA Determined
Cause 2		 Employee error
Action The recall was initiated via phone on 7/21/2017 requesting the customer return the product for replacement if they routinely use the control wells.
Quantity in Commerce 24 kits
Distribution Distribution was made to IN, KY, MA, OH, OR, TN, and TX. There was government distribution. Foreign distribution was made to 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = CFF and Original Applicant = HELENA LABORATORIES
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