Company: Tosoh Bioscience Inc
Date of Enforcement Report: 12/14/2018
Class II
PRODUCT
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.
Recall Number: Z-0613-2019
REASON
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.
RECALLING FIRM/MANUFACTURER
Tosoh Bioscience Inc, Grove City, OH on 3/22/2017. Voluntary: Firm Initiated, recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
438
DISTRIBUTION
U.S. Nationwide and International