Tosoh Bioscience Inc: 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

Recalling firm

Tosoh Bioscience Inc

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.

Status

Terminated

Initiated

2017-03-22

Posted

not on file

Terminated

2020-12-09

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.

Root cause

Process control

Action

On October 5, 2018, the firm notified customers of the recall via Urgent Medical Device Recall letter. Customers were informed of the potential issue with the analyzer that could prevent the table home sensor from detecting the table home position. Customers were advised that the table home sensor board will be evaluated and replaced if needed at the next scheduled preventive maintenance visit. Actions to be taken by User: " Thoroughly review the content of this letter. " Continue to use your analyzer. A Tosoh representative will contact you to schedule your next preventive maintenance visit. o If you experience any problems, please contact Tosoh Technical Support for an expedited service visit. " Complete and return the attached Acknowledgement Form. " File this notice with your laboratory records and forward this information to others in your laboratory. If you have obtained unexpected test results, delays in test result reporting , or received any complaints of illness or adverse events associated with the use of the analyzer, please contact Tosoh Technical Support 24 hours a day, seven days a week at (800) 248-6764. Should you have any questions regarding this medical device recall, please feel free to contact Bernadette O'Connell at (800) 248-6764 or by email at bernadette.oconnell@tosoh.com. She will be available to answer any questions Monday- Friday, from 9:00 AM to 5:00 PM (PST).

Quantity

438

Distribution

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

Lot, serial or model codes

All units with serial numbers prior to "1701"

510(k) numbers

not on file

PMA numbers

not on file

Product code

KHO

Firm FEI

3005529799

Firm city

Grove City

Firm state

OH

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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