Z-0613-2019Class II

AIA-360 Analyzer is capable of performing two methods of immunoassay: an immunoenzymetric (IEMA) or sandwich...

Name: Z-0613-2019 AIA-360 Analyzer is capable of performing two methods of immunoassay: an immunoenzymetric (IEMA) or sandwich...
Creator: Tosoh Bioscience Inc
Published: 2017-03-22
License: https://open.fda.gov/license/

Tosoh Bioscience Inc / initiated 2017-03-22 / Terminated / root cause: manufacturing process

FDA source

Tosoh Bioscience Inc began a recall of AIA-360 Analyzer is capable of performing two methods of immunoassay: an immunoenzymetric (IEMA) or sandwich immunoassay, a competitive binding (EIA)... on 2017-03-22. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0613-2019
Classification: Class II
Status: Terminated
Initiated: 2017-03-22
Posted: 2018-12-14
Terminated: 2020-12-09
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.
Product code: KHO Fluorometer, For Clinical Use
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.
Root cause tag: manufacturing process
FDA 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 [email protected]. She will be available to answer any questions Monday- Friday, from 9:00 AM to 5:00 PM (PST).
Quantity in commerce: 438
Distribution: Nationwide distribution. International distribution to Honduras, Caribbean, Chile, Colombia, Costa Rica, Uruguay, Ecuador, Panama, Mexico, Canada, and Venezuela.
Product codes and lots: All units with serial numbers prior to "1701"

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0613-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0613-2019	Class II	Terminated	Voluntary: Firm initiated	2018-12-26	2018-12-14

Product code KHO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)