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U.S. Department of Health and Human Services

Class 2 Device Recall AIA900 Automated Immunoassay Analyzer

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  Class 2 Device Recall AIA900 Automated Immunoassay Analyzer see related information
Date Initiated by Firm October 05, 2018
Create Date November 28, 2018
Recall Status1 Terminated 3 on August 27, 2020
Recall Number Z-0509-2019
Recall Event ID 81212
Product Classification Fluorometer, for clinical use - Product Code KHO
Product AIA-900 Automated Immunoassay Analyzer, product code 022930 /022930R

Product Usage:
The AIA-900 is capable of performing three methods of immunoassay: an immunoenzymetric (IEMA) or sandwich immunoassay, a competitive binding (EIA) immunoassay, and a two-step immunoenzymetric 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 Serial nos. 10142204 10373208 10493811 10614102 10212711 10403809 10503612 10634103 10253102R 10463110 10513412 10654404
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 axis base of the turntable rotation drive motor on the AIA-900 Analyzer. If the tension of the timing belt between the turntable rotation pulley and drive motor is not adjusted correctly, it is possible to increase the lateral load on the motor axis resulting in the inclination and damage of the motor axis. Since January 12, 2017, Tosoh has been inspecting the tension of the timing belt during scheduled preventative maintenance visit and correcting the analyzers where this issue has been observed. If the drive motor 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 has received five (5) complaints related to this issue with no serious injuries reported.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action On October 5, 2018, the firm issued an Urgent Medical Device Recall - Correction letter to affected customers. The letter described the product issue and advised customers that since January 12, 2017, Tosoh has been inspecting the tension of the timing belt during scheduled preventative maintenance visit and correcting the analyzers where this issue has been observed. Serial numbers of affected AIA-900 analyzers which have not yet been inspected were provided as a list. Immediate Actions to be taken by the Customer/User " Thoroughly review the content of the letter. " 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. " Complete and return the attached Acknowledgement Form by any of the listed methods. " Identify if the serial number of your AIA-900 analyzer is listed in the letter, contact Technical Support to schedule a preventative maintenance service visit. At the scheduled visit, allow the Tosoh field service engineer to inspect and verify that the axis base of the turntable rotation drive motor is operating as expected or allow the Tosoh field service engineer to correct the potential issue. " If the serial number of your analyzer is not listed, Tosoh service records indicate that the turntable rotation drive motor on your instrument(s) has already been inspected. 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 for an expedited service visit. 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
Quantity in Commerce 247
Distribution Worldwide Distribution - US Nationwide in the states of FL, MD, NV, NY, SC, and TX. and Foreign distribution to Cayman Islands, Chile, Columbia, Dominican Republic, Ecuador, Guatemala, Honduras, 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.
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