Tosoh Bioscience Inc: Medical Device Recall in 2018 - (Recall #: Z-0613-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: March 22, 2017

Date Posted: December 26, 2018

Recall Number: Z-0613-2019

Event ID: 81170

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.

Status: Terminated

Product Quantity: 438

Code Information:

All units with serial numbers prior to "1701"

Distribution Pattern:

Nationwide distribution. International distribution to Honduras, Caribbean, Chile, Colombia, Costa Rica, Uruguay, Ecuador, Panama, Mexico, Canada, and Venezuela.

Voluntary or Mandated:

Voluntary: Firm initiated