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U.S. Department of Health and Human Services

Class 3 Device Recall Gel Alkaline Phosphatase Isoenzyme Control Kit

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  Class 3 Device Recall Gel Alkaline Phosphatase Isoenzyme Control Kit see related information
Date Initiated by Firm November 07, 2016
Create Date November 30, 2018
Recall Status1 Terminated 3 on January 15, 2021
Recall Number Z-0529-2019
Recall Event ID 81303
510(K)Number K895528  
Product Classification Single (specified) analyte controls (assayed and unassayed) - Product Code JJX
Product Gel Alkaline Phosphatase Isoenzyme Control Kit:

Gel Alkaline Phosphatase Isoenzyme Control Cat. No. 5104 1 x 2.0 mL FOR IN-VITRO DIAGNOSTIC USE

Gel Alkaline Phosphatase Isoenzyme Control 20mL 001831

Alkaline Phosphatase Isoenzyme Control is to be used as a qualitative and/or quantitative control to aid in the identification of alkaline Phosphatase isoenzymes by electrophoresis.
Code Information " Lot Codes: 1-16-5104 (Scheme: 1(st lot)-(of 20)16-(for C/N )5104) " Model/Catalog Number: 5104 " UDI: Primary DI - M52551040 
Recalling Firm/
Manufacturer		 Helena Laboratories, Inc.
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 a customer experiencing complaints on bone fraction of assay not being in range. The complaint: ~12% lower enzyme activity was noted.
FDA Determined
Cause 2		 Unknown/Undetermined by firm
Action On 11/02/2016, the firm, Helena Laboratories, Inc., sent a "Withdrawal Notification" to customers via email. The notice described the product, problem and actions to be taken. The customers were instructed remove lot from inventory and discard; contact technical services at 1-800-231-5663 ext.1600 for MRA#; and complete Withdrawal Notification form and return copy to Helena Laboratories via FAX at:409-842-1874 or email to: jjones@helena.com. The firm is doing a Withdrawal of this lot, and will replace this material, if they have not already done so, with a new kit lot. If the customer indicates how many kits it has remaining, the firm will forward replacement, under Material Return Authorization and to use an enclosed form to report replacement needs. Customers are informed to contact Technical Services is 1-800-231-5663, Ext. 1600; for MRA#, and for questions, to contact Jessica Jones at extension 1177, or email jjones@helena.com. The firm's public contact may be reached at (409)842-3714 extension 1177.
Quantity in Commerce 43 kits (6 kits Domestic/37 Internationally)
Distribution Worldwide Distribution: US (nationwide) to states of: GA, IN, and MI, and countries of: Australia, Brazil, Canada, Japan and Hong Kong.
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 = JJX and Original Applicant = HELENA LABORATORIES
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