Class 2 Device Recall AIA360 Analyzer

• Date Initiated by Firm: March 22, 2017
• Create Date: December 14, 2018
• Recall Status: Terminated on December 09, 2020
• Recall Number: Z-0613-2019
• Recall Event ID: 81170
• Product Classification: Fluorometer, for clinical use - Product Code KHO
• Product: AIA-360 Analyzer is capable of performing two methods of immunoassay: an immunoenzymetric (IEMA) or sandwich immunoassay, a competitive binding (EIA) immunoassay. An antigen-antibody reaction begins by combining a patient sample, control, or calibrator with a diluent in an immunoreaction test cup from the AIA-PACK reagent series.
• Code Information: All units with serial numbers prior to "1701"
• FEI Number: 3005529799
• Recalling Firm/ Manufacturer: Tosoh Bioscience Inc; 3600 Gantz Rd; Grove City OH 43123-1895
• For Additional Information Contact: 614-317-1909
• Manufacturer Reason for Recall: The firm has become aware of a potential issue with the AIA-360 analyzer that could prevent the table home sensor from detecting the table home position. If the malfunction with the table home sensor occurs on the AIA-360, the sensor board may need to be replaced. If the home sensor fails to detect the home position, the AIA-360 analyzer will cease to function and will be unavailable for use. If this issue occurs, there may be a delay in testing and reporting patient test results. Tosoh has received three (3) complaints related to this issue with no serious injuries reported.
• FDA Determined Cause: Process control
• Action: On October 5, 2018, the firm notified customers of the recall via Urgent Medical Device Recall letter. Customers were informed of the potential issue with the analyzer that could prevent the table home sensor from detecting the table home position. Customers were advised that the table home sensor board will be evaluated and replaced if needed at the next scheduled preventive maintenance visit. Actions to be taken by User: " Thoroughly review the content of this letter. " Continue to use your analyzer. A Tosoh representative will contact you to schedule your next preventive maintenance visit. o If you experience any problems, please contact Tosoh Technical Support for an expedited service visit. " Complete and return the attached Acknowledgement Form. " 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: 438
• Distribution: Nationwide distribution. International distribution to Honduras, Caribbean, Chile, Colombia, Costa Rica, Uruguay, Ecuador, Panama, Mexico, Canada, and Venezuela.
• 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.