Class 2 Device Recall AIA900 Analyzer

• Date Initiated by Firm: October 05, 2018
• Create Date: November 14, 2018
• Recall Status: Terminated on November 10, 2020
• Recall Number: Z-0469-2019
• Recall Event ID: 81187
• Product Classification: Fluorometer, for clinical use - Product Code KHO
• Product: AIA-900 Analyzer, Product code 022930, 022930R
• Code Information: All units are affected
• FEI Number: 3005529799
• 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 a potential issue with the pickup arm and pickup arm motor on the AIA-900 Analyzer. If the pickup arm or pickup arm motor malfunctions, the analyzer will cease to function and result in an inability to test patient samples. This may cause a delay in testing and reporting patient results. Tosoh has received fifty-one (51) complaints related to this issue with no serious injuries reported.
• FDA Determined Cause: Device Design
• Action: On October 5, 2018, the firm notified its affected customers via an Urgent Medical Device Recall letter. The letter informed customers of the potential product issue with all active AIA-900 analyzers. The firm's service procedures have been updated to proactively troubleshoot and correct the pickup arm and pickup arm motor during installations and scheduled preventive maintenance visits. At the next scheduled preventive maintenance visit a Tosoh field service engineer will verify the pickup arm motor current and adjust as needed. Adherence to preventive maintenance schedules provides effective mitigation against potential failure of these components. Immediate Actions to be taken by the Customer/User " Thoroughly review the content of this letter. " Continue to use the instrument. A Tosoh representative will contact you to schedule your next preventive maintenance visit. o If a failure of the pickup arm is observed or the analyzer stops functioning, contact Tosoh Technical Support for an expedited service visit. " Complete and return the attached Acknowledgement Form by any of the listed methods. " File this notice 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: 393
• Distribution: Distributed nationwide. Foreign distribution to Canada and Latin America.
• 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.