Class 2 Device Recall AIA900 Automated Immunoassay Analyzer

• Date Initiated by Firm: September 28, 2017
• Create Date: December 13, 2018
• Recall Status: Terminated on December 08, 2020
• Recall Number: Z-0602-2019
• Recall Event ID: 81172
• Product Classification: Fluorometer, for clinical use - Product Code KHO
• Product: AIA-900 Automated Immunoassay Analyzer performs three methods of immunoassay: an immunoenzymetric (IEMA) or sandwich immunoassay, a competitive binding (EIA) immunoassay, and a two-step immunoenzymetric immunoassay.
• Code Information: All active analyzer serial numbers
• Recalling Firm/ Manufacturer: Tosoh Bioscience Inc; 3600 Gantz Rd; Grove City OH 43123-1895
• For Additional Information Contact: Bernadette O'Connell; 800-248-6764
• Manufacturer Reason for Recall: The firm has become aware of a potential issue that may affect the mixing motor drive harness and mixing home detection sensor relay harness on your AIA-900 Analyzer. It is possible that the harnesses could rub against the Plarail chain during operation and result in premature wear. If observed, this issue will cause the following system error to be reported D.lane Mix home overrun error [4093] . If observed, this issue will cause the AIA-900 Analyzer not to function and the D.lane Mix home overrun error [4093] will be reported by the system. Replacement of the motor drive harness and mixing home detection sensor relay harness will mitigate the potential for premature wear and effectively prevent this issue from causing the system error. If the sensor relay harness fails, the AIA-900 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 is aware of two complaints associated with the unexpected wearing of the harness. There have been no user or patient injuries reported that are related to this device malfunction.
• FDA Determined Cause: Component design/selection
• Action: On September 28, 2018, the firm notified customers via Urgent Medical Device Recall letter. Customers were informed of the potential issue. Immediate Actions to be taken by the Customer: Thoroughly review the content of this letter. " Identify if the serial number of your analyzer is listed in this notification. o If the serial number of your analyzer is listed: 1. At the next service call or scheduled PM, whichever occurs first, a Tosoh field service engineer will verify the motor drive harness and mixing home detection sensor relay harness are bundled together and placed into a double-coated cable or repair the harness bundle as applicable. 2. Complete and return the attached Acknowledgement Form by any of the listed methods. o If the serial number of your analyzer is not listed: 1. Tosoh records indicate that the harness bundle on your instrument(s) has already been replaced. 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 other supervisors or managers in your laboratory to ensure that they are aware of the potential issue.
• Quantity in Commerce: 258
• Distribution: Nationwide distribution. Foreign distribution to Chile, Colombia, Ecuador, Guatemala, Honduras, Panama, Peru, Puerto Rico, Uruguay, 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.