Class 2 Device Recall Tosoh ST AIAPACK HbA1c Control

• Date Initiated by Firm: March 05, 2018
• Create Date: May 14, 2018
• Recall Status: Terminated on June 16, 2020
• Recall Number: Z-1811-2018
• Recall Event ID: 79708
• Product Classification: Multi-analyte controls, all kinds (assayed) - Product Code JJY
• Product: Tosoh ST AIA-PACK HbA1c Control, HbA1c Control, PN 025418 The product is intended for In Vitro Diagnostic Use Only for performing quality control procedures with the HbA1c Assay.
• Code Information: All lots.
• Recalling Firm/ Manufacturer: Tosoh Bioscience Inc; 3600 Gantz Rd; Grove City OH 43123-1895
• For Additional Information Contact: Tosoh Technical Support; 800-248-6764
• Manufacturer Reason for Recall: The assay can potentially generate erroneously elevated or erroneously decreased HbA1c patient results.
• FDA Determined Cause: Nonconforming Material/Component
• Action: On March 5, 2018, the firm notified all customers who have received product since 2011 of the discontinuation of this product from the market. Customers were instructed to immediately discontinue use of all lot numbers of recalled test and components, remove all recalled materials from inventory, and destroy per the customer's local procedures. Customers were also instructed to notify and forward the information to physicians who have received test results provided by recalled products over the past 6 months to determine if follow up testing is required. Customers were advised that the recalling firm is permanently removing all ST AIA-PACK HbA1c test and components from the market, and were instructed to identify an alternative test option for HbA1c. Customers were asked to complete and return the Recall Acknowledgement Form to the recalling firm. Customers may contact Tosoh Technical Support at 1(800)-248-6764, 8AM-5PM PST (voice mail after hours), seven days a week.
• Quantity in Commerce: 2864
• Distribution: USA (nationwide) Distribution including PR and to the states of : AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, KS, KY, LA, MA, MD, MI, MO, NC, NE, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY.
• 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.