Class 2 Device Recall AIAPACK BHCG Calibration Verification Test set

• Date Initiated by Firm: August 07, 2020
• Date Posted: September 14, 2020
• Recall Status: Terminated on June 21, 2021
• Recall Number: Z-2968-2020
• Recall Event ID: 86218
• Product Classification: Single (specified) analyte controls (assayed and unassayed) - Product Code JJX
• Product: Tosoh Bioscience AIA-PACK BHCG Calibration Verification Test Set-In Vitro Diagnostic for BHCG-pregnancy Part number: 020661 The AIA-Pack BHCG Calibrator Set is intended for IN VITRO DIAGNOSTIC USE ONLY for the calibration of the ST AIA-PACK BHCG assay
• Code Information: Lot Numbers: J803507, JX03508, JZ03509, A203510, A403511
• Recalling Firm/ Manufacturer: Tosoh Bioscience Inc; 3600 Gantz Rd; Grove City OH 43123-1895
• For Additional Information Contact: Bernadette OConnell; 800-248-6764
• Manufacturer Reason for Recall: Decreased stability for five (5) lots of Calibrator Sets and Calibration Verification Test Sets, resulting in a decrease measured concentration of HCG up to 20%.
• FDA Determined Cause: Under Investigation by firm
• Action: The firm, Tosoh Bioscience, issued an "URGENT: MEDICAL DEVICE RECALL" Letter dated August 7, 2020 via Fedex to its customers. The letter states reason for recall, health risk and action to taken: Check the lot numbers of the AIA - PACK HCG Calibrator Set and AIA-PACK HCG Calibration Verification Test Set against the lot numbers listed above. Lots not listed above are not within the scope of this recall and maybe used per AAM. Remove all affected AIA - PACK HCG Calibrator Sets and AIA - PACK HCG Calibration Verification Test Sets from your inventory. The products must be tallied including previously used sets of the affected lots and properly destroyed per your local procedures and regulations. For reimbursement of destroyed calibrator and linearity sets, please contact Technical Support. Reimbursement will be with same or similar products. Review the information in this notification with the Medical Director and/or Lab Director as soon as possible and review the content of this letter with your laboratory staff Complete and return the attached Acknowledgement Form to Tosoh Bioscience, Inc., within 15-days of receiving this notification via Fax: 1-650-636-8651 or Email: biorecallresponse@tosoh.com or by US Post Mail: Be sure to indicate destruction of affected product(s). Tosoh Bioscience Inc. 3600 Gantz Rd. Grove City, OH 4312. Maintain this notification with your laboratory records and forward this information to others in your laboratory. If you have obtained unexpected test results 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 OConnell at (800) 248-6764 or by email at bernadette.oconnell@tosoh.com. Monday - Friday, from 9:00 AM to 5:00 PM (PST).
• Quantity in Commerce: 39 boxes
• Distribution: Worldwide Distribution: US (Nationwide) and countries of: Bogota, Cayman Islands, Mexico, Peru, and San Salvador.
• 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.