Z-0559-2019Class II

AIA-360 Analyzer, product code 019945/019945R The Tosoh AIA-360 Automated Immunoassay Analyzer is for use in...

Name: Z-0559-2019 AIA-360 Analyzer, product code 019945/019945R The Tosoh AIA-360 Automated Immunoassay Analyzer is for use in...
Creator: Tosoh Bioscience Inc
Published: 2018-08-23
License: https://open.fda.gov/license/

Tosoh Bioscience Inc / initiated 2018-08-23 / Terminated / root cause: labeling and UDI

FDA source

Tosoh Bioscience Inc began a recall of AIA-360 Analyzer, product code 019945/019945R The Tosoh AIA-360 Automated Immunoassay Analyzer is for use in vitro diagnostic to provide testing for a broad... on 2018-08-23. FDA classified it as Class II and gives the reason as "The firm has implemented new product labeling changes for the Tosoh AIA-360 Analyzer. These labeling changes affect the Tosoh Quick Reference Guide, Training Manual and Training DVD previously provided by Tosoh...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0559-2019
Classification: Class II
Status: Terminated
Initiated: 2018-08-23
Posted: 2018-12-06
Terminated: 2020-10-20
Recalling firm: Tosoh Bioscience Inc
Product: AIA-360 Analyzer, product code 019945/019945R The Tosoh AIA-360 Automated Immunoassay Analyzer is for use in vitro diagnostic to provide testing for a broad menu of assays in a unique patented dry reagent format.
Product code: KHO Fluorometer, For Clinical Use
Reason for recall: The firm has implemented new product labeling changes for the Tosoh AIA-360 Analyzer. These labeling changes affect the Tosoh Quick Reference Guide, Training Manual and Training DVD previously provided by Tosoh Bioscience. These changes are being made to align the Tosoh Quick Reference Guide and associated training materials to the Operators Manual and provide clarification to the requirement that the maintenance of the B/F probe is to be performed by Tosoh a field service representative, the requirement for use of 70% Ethanol during daily shutdown procedures and the requirement for use of CAP Class 1 reagent grade water for dilution of the concentrated wash and diluent solutions and reconstitution of lyophilized reagents. Failure to follow these requirements may negatively affect system performance, lead to corrosion of instrument components over time, or result in bacterial contamination, respectively.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: On August 23, 2018, the firm, Tosoh Bioscience, notified affected distributors and customers via "URGENT: MEDICAL DEVICE RECALL" letter. The described the product, problem and actions to be taken. Summary and location of labeling changes: - Elimination of monthly B/F probe maintenance. - Added requirement for use of 70% Ethanol. - Added requirement for use of CAP Class l reagent grade water per CLSI Guidelines and Standards. - Added clarification of substrate stability. Substrate, when stored at 2-8C between uses is stable for 30 days. Customers were asked to do the following: -Discontinue maintenance activities on the B/F probe. If issues with the B/F probe are observed, call Technical Support for assistance. - Please continue to perform all your other maintenance procedures at the required intervals as per the instructions in the Operators Manual. - Discard the Training DVD, it is now obsolete. An updated version of the Training DVD, QRG and Training Manual will be sent to you in a separate mailing. - At daily shutdown, use 70% Ethanol to replace the substrate solution. - Use only CAP Class l reagent grade water. - Complete and return the attached Acknowledgement Form to Tosoh Bioscience, Inc., within 15-days of receiving this notification. - Maintain this notification with your laboratory records and forward this information to others who may have received this product. - If you have obtained unexpected test results or received any complaints of illness or adverse events associated with the use of these products, 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 contact call (800) 248-6764 or email at [email protected] Monday - Friday, from 9:00 AM to 5:00 PM (PST).
Quantity in commerce: 1228
Distribution: Worldwide Distribution: US (Nationwide) and countries of: Mexico, Canada, Colombia, Chile, Venezuela, Ecuador, Uruguay, Peru, and Honduras.
Product codes and lots: Change to labeling affects all devices.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0559-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0559-2019	Class II	Terminated	Voluntary: Firm initiated	2018-12-12	2018-12-06

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)