Class 3 Device Recall Hemoglobin A1c Control

• Date Initiated by Firm: October 05, 2018
• Create Date: December 13, 2018
• Recall Status: Terminated on June 16, 2020
• Recall Number: Z-0601-2019
• Recall Event ID: 81188
• 510(K)Number: K021484
• Product Classification: Assay, glycosylated hemoglobin - Product Code LCP
• Product: Hemoglobin A1c Control, Part no. 220232 for use as quality control material to monitor the precision of laboratory testing procedures for HbA1c quantitation.
• Code Information: Lot 7055
• Recalling Firm/ Manufacturer: Tosoh Bioscience Inc; 3600 Gantz Rd; Grove City OH 43123-1895
• For Additional Information Contact: Ms. Bernadette O'Connell; 800-248-6764
• Manufacturer Reason for Recall: Tosoh Bioscience has become aware of potential degradation of HbA1c control lot # 7055 before the 60-days product stability claim. If degradation of these controls occurs, P00 peaks may be seen and the % HbA1c control values may drift higher than the assigned range. This may result in delays when performing routine instrument quality control. If this issue occurs, there may be a delay in testing and reporting patient test results. Tosoh has received two (2) complaints related to this issue with no serious injuries reported.
• FDA Determined Cause: Device Design
• Action: The firm sent notification to consignees on October 5, 2018, via Urgent Medical Device Recall letter. The letter informed consignees of the potential degradation of HbA1c control lot 7055 prior to the 60-days product stability claim. Immediate Actions to be taken by the Customer " Review the content of this letter with your laboratory staff. " Inform laboratory staff to avoid storing the control material in direct exposure to light. " Complete and return the attached Acknowledgement Form to Tosoh Bioscience, Inc., within 15-days of receiving this notification. " In the event of an early degradation of the control material, new controls should be used to verify the instrument performance prior to use. " Maintain this notification with your laboratory records and forward this information to others in your laboratory. " If you have obtained unexpected test results, delays in test result reporting, or received any complaints of illness or adverse events associated with the use of the analyzer, please contact Tosoh Technical Support 24 hours a day, seven days a week at (800) 248-6764. " Should you have any questions regarding this medical device recall, please feel free to contact Bernadette O'Connell at (800) 248-6764 or by email at bernadette.oconnell@tosoh.com. She will be available to answer any questions Monday - Friday, from 9:00 AM to 5:00 PM (PST).
• Quantity in Commerce: 1000
• Distribution: Distributed nationwide. Foreign distribution to Canada.
• 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 = LCP