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.
Enforcement
- Recall Number
- Z-0509-2019
- Event ID
- 81212
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Tosoh Bioscience Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- December 5, 2018
- Initiation Date
- October 5, 2018
- Classification Date
- November 28, 2018
- Termination Date
- August 27, 2020
- Address
- 3600 Gantz Rd, N/A, Grove City, OH, 43123-1895, United States
Description
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.
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.
Serial nos. 10142204 10373208 10493811 10614102 10212711 10403809 10503612 10634103 10253102R 10463110 10513412 10654404
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.
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