Z-0613-2019 Class II Terminated
FDA device recall Z-0613-2019 was initiated by Tosoh Bioscience Inc on March 22, 2017 and is designated Class II. Reason for recall: The firm has become aware of a potential issue with the AIA-360 analyzer that could prevent the table home sensor from detecting the table home position. If the malfunction with the table home sensor … The recall status is terminated (terminated December 9, 2020). Affected quantity: 438.
Recall Details
- Product Type
- Devices
- Report Date
- December 26, 2018
- Initiation Date
- March 22, 2017
- Termination Date
- December 9, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 438
Product Description
AIA-360 Analyzer is capable of performing two methods of immunoassay: an immunoenzymetric (IEMA) or sandwich immunoassay, a competitive binding (EIA) 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.
Reason for Recall
The firm has become aware of a potential issue with the AIA-360 analyzer that could prevent the table home sensor from detecting the table home position. If the malfunction with the table home sensor occurs on the AIA-360, the sensor board may need to be replaced. If the home sensor fails to detect the home position, the AIA-360 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 three (3) complaints related to this issue with no serious injuries reported.
Distribution Pattern
Nationwide distribution. International distribution to Honduras, Caribbean, Chile, Colombia, Costa Rica, Uruguay, Ecuador, Panama, Mexico, Canada, and Venezuela.
Code Information
All units with serial numbers prior to "1701"