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U.S. Department of Health and Human Services

Class 2 Device Recall Titan Gel Serum Protein Control (SPE Control)

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  Class 2 Device Recall Titan Gel Serum Protein Control (SPE Control) see related information
Date Initiated by Firm October 14, 2016
Create Date August 30, 2019
Recall Status1 Terminated 3 on October 12, 2023
Recall Number Z-2434-2019
Recall Event ID 81383
510(K)Number K821982  
Product Classification Multi-analyte controls, all kinds (assayed) - Product Code JJY
Product Titan Gel Serum Protein Control: SPE Control Cat. No 5136 1 x 2.0 mL
Code Information Lot Codes: 1-16-5136 (Scheme: 1(st lot)-(of 20)16-(for C/N )5136)  LOT 1-16-5136 EXP 3-17  Model/Catalog Number: 5136  UDI: Primary DI - M52551360 
Recalling Firm/
Manufacturer		 Helena Laboratories, Inc.
1530 Lindbergh Dr
Beaumont TX 77707-4131
For Additional Information Contact Dr. Jessica Hanka
409-842-3714 Ext. 1177
Manufacturer Reason
for Recall		 Due to customer-experienced complaints on narrow assay range compared to prior lots and the user being out of assay range.
FDA Determined
Cause 2		 Process control
Action Between 10/14/2016 to 10/21/2016 a notification was emailed to the affected users informing them that Assay protocol had changed due to a Marketing decision to delete use of EDC, since it was a discontinued device (for over 10 years), creating a tighter assay range, but met QC specification. Due to customer-experienced complaints on narrow assay range compared to prior lots and the user being out of assay range, Technical Services began an MRA investigation. Investigation verified user complaint, and Lot was quarantined, and Rework action plans using EDC also were initiated for the device. This issue was found at a Users site, via use as system Quality Control material. The investigation focused on potential effects/risks, and cause. This issue was found at a Users site, via use as system Quality Control material. Customers reported a narrow assay range when compared to prior lots forcing some users out of the provided assay range. PUBLIC CONTACT: Title: Technical Services Manager Address: 1530 Lindbergh Drive, Beaumont, TX 77707 Telephone #: (409) 842-3714 x1177 Email: jhanka@helena.com
Quantity in Commerce 65 kits
Distribution Domestic: FL, IL, MN, MT, NY, OH, TN, TX, VA, and WI OUS: Australia, Canada, Jordan, and South Korea
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 = JJY and Original Applicant = HELENA LABORATORIES
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