Recall Z-0509-2019 ยท KHO Fluorometer, For Clinical Use
Tosoh Bioscience Inc
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
| Date | Oct 5, 2018 |
| Status | Terminated |
| Reason | 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 |
| Root cause | 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 yo |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.