Class 2 Device Recall AIA2000 Analyzer

• Date Initiated by Firm: September 28, 2018
• Create Date: December 13, 2018
• Recall Status: Terminated on September 03, 2020
• Recall Number: Z-0599-2019
• Recall Event ID: 81190
• Product Classification: Fluorometer, for clinical use - Product Code KHO
• Product: AIA-2000 Analyzer, Product code 022100, 022100R, 022101, 022101R The AIA-2000 analyzer and AIA-900 analyzer are capable of performing three methods of immunoassay: an immunoenzymetric (IEMA) or sandwich immunoassay, a competitive binding (EIA) immunoassay, and a two-step immunoenzymetric immunoassay.
• Code Information: Affects all active analyzers. 022100, 022100R, 022101, 022101R
• 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 AIA-900 and AIA-2000 analyzers that could result in slippage of the incubator unit contained within the system. If the tension of the timing belt is not adjusted correctly, it is possible for a misalignment that will result in a mechanical error. Tosoh has taken the required actions to inspect the tension of the timing belt during preventative maintenance and correct the instruments where this issue has been observed. If incubator slippage occurs, the unit will cease to function, and a system error will be reported. If this occurs, there may be a delay in testing and reporting patient test results. There have been no reports of injury related to this issue.
• FDA Determined Cause: Process control
• Action: On September 28, 2018, the firm, Tosoh Bioscience, notified consignees via an "URGENT: MEDICAL DEVICE RECALL" letter. The letter described the product, problem and actions to be taken. The letter informed customers that the AIA-900 and AIA -2000 analyzers had a potential issue that could result in slippage of the incubator unit within the system. Immediate Actions to be taken by the Customer/User " Thoroughly review the content of this letter. " Continue to use your Instrument. o Contact Tosoh Technical Support if mechanical errors occur. o The tension of the timing belt will be assessed and adjusted as needed at the next scheduled preventive maintenance visit. " Complete and return the attached Acknowledgement Form via Fax to: 1-605-636-8651; email: biorecallresponse@tosoh.com or mail to: Recall Coordinator, Tosoh Bioscience, Inc., 3600 Gantz Road, Grove City, OH 43123. " 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 call (800) 248-6764 or email: bernadette.oconnell@tosoh.com Monday - Friday, from 9:00 AM to 5:00 PM (PST).
• Quantity in Commerce: 95
• Distribution: US Nationwide distribution and International distribution to Colombia, Chile, Honduras, Cayman Islands, Panama, Costa Rica, Guatemala, Venezuela, Uruguay, Peru, and Ecuador.
• 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.