Class 3 Device Recall SPIFE Alkaline Hemoglobin Kit

• Date Initiated by Firm: February 27, 2018
• Create Date: November 05, 2019
• Recall Status: Open, Classified
• Recall Number: Z-0297-2020
• Recall Event ID: 83925
• 510(K)Number: K982426
• Product Classification: System, analysis, electrophoretic hemoglobin - Product Code JBD
• Product: SPIFE Alkaline Hemoglobin Kit, Cat. No. 3415, for use in the separation and quantitation of hemoglobins by agarose electrophoresis using the SPIFE systems
• Code Information: Lot Codes [Scheme: 62(nd lot)-(of 20)17-(for C/N)551977]: " Lot 62-17-551977 " Lot 63-17-551977 " Lot 64-17-551977 " Lot 65-17-551977 " Lot 66-17-551977 " Lot 67-17-551977 " Lot 68-17-551977 " Lot 69-17-551977 " Lot 70-17-551977 " Lot 71-17-551977 " Lot 72-17-551977 " Lot 1-18-551977, " Lot 2-18-551977 " Lot 3-18-551977 " Lot 4-18-551977 " Lot 5-18-551977 " Lot 6-18-551977 " Lot 7-18-551977 " Lot 8-18-551977 " Lot 9-18-551977 " Lot 10-18-551977 " Lot 11-18-551977 " Lot 12-18-551977 " Lot 13-18-551977 The expiration date for all 2017-manufactured lots is 9/30/18. The expiration date for Lot 1 through Lot 11 of 2018 is 10/31/18. The expiration date for Lot 12 and Lot 13 of 2018 is 12/31/18.
• FEI Number: 1618982
• 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: Lots of gel kits contained a newer revision of the Customer Procedures instructions than intended. The incorrect inserts refer to updated parameters associated with new electrodes -- which have not yet been made available to users.
• FDA Determined Cause: Labeling mix-ups
• Action: On 2/27/2018, Helena's Technical Services contacted customer via phone call. In addition, consignees were emailed the recall notification. During the call/ communicated the following We would like to make you aware that you recently received a lot of SPIFE Alkaline Hemoglobin Gel kits, Catalog number 551977, which contained a revised procedural insert. This procedural version was released earlier than intended. The kits affected include the following lots: If you utilized the new testing parameters in the kit, the only noticeable effects would be increased pattern lengths, which would not affect quantitation or interpretation. Please discard the procedural inserts included in the kit received, and replace with the attached procedural insert(s), which contain the same instructions you have historically used: The incorrect inserts refer to updated parameters associated with new electrodes -- which have not yet been made available to users -- as well as several improvements in the SPIFE Alkaline Hemoglobin gels that we anticipate will be released in the near future. At that time, additional instructions and information regarding the change will be made available to you. We apologize for any inconvenience this may have caused. Please contact Technical Services at 1-800-231-5663, EXT 1600 if you have any questions.
• Quantity in Commerce: 899 kits
• Distribution: US: OH, NY, MI, IN, IL, MS, TX, CT, NJ, KY, FL, MD, GA, PA, AZ, MO, VA, SC, LA, KS, WA, WI, OUS: Colombia, Brasil, Taiwan
• 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 = JBD