26

Dec

2018

Recall – Immunoassay analyzer detection failure

0

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

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