Z-0469-2019Class II

AIA-900 Analyzer, Product code 022930, 022930R

Name: Z-0469-2019 AIA-900 Analyzer, Product code 022930, 022930R
Creator: Tosoh Bioscience Inc
Published: 2018-10-05
License: https://open.fda.gov/license/

Tosoh Bioscience Inc / initiated 2018-10-05 / Terminated / root cause: design

FDA source

Tosoh Bioscience Inc began a recall of AIA-900 Analyzer, Product code 022930, 022930R on 2018-10-05. FDA classified it as Class II and gives the reason as "Tosoh Bioscience has become aware of a potential issue with the pickup arm and pickup arm motor on the AIA-900 Analyzer. If the pickup arm or pickup arm motor malfunctions, the analyzer will cease to function and result...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0469-2019
Classification: Class II
Status: Terminated
Initiated: 2018-10-05
Posted: 2018-11-14
Terminated: 2020-11-10
Recalling firm: Tosoh Bioscience Inc
Product: AIA-900 Analyzer, Product code 022930, 022930R
Product code: KHO Fluorometer, For Clinical Use
Reason for recall: Tosoh Bioscience has become aware of a potential issue with the pickup arm and pickup arm motor on the AIA-900 Analyzer. If the pickup arm or pickup arm motor malfunctions, the analyzer will cease to function and result in an inability to test patient samples. This may cause a delay in testing and reporting patient results. Tosoh has received fifty-one (51) complaints related to this issue with no serious injuries reported.
Root cause tag: design
FDA root cause: Device Design
Action: On October 5, 2018, the firm notified its affected customers via an Urgent Medical Device Recall letter. The letter informed customers of the potential product issue with all active AIA-900 analyzers. The firm's service procedures have been updated to proactively troubleshoot and correct the pickup arm and pickup arm motor during installations and scheduled preventive maintenance visits. At the next scheduled preventive maintenance visit a Tosoh field service engineer will verify the pickup arm motor current and adjust as needed. Adherence to preventive maintenance schedules provides effective mitigation against potential failure of these components. Immediate Actions to be taken by the Customer/User " Thoroughly review the content of this letter. " Continue to use the instrument. A Tosoh representative will contact you to schedule your next preventive maintenance visit. o If a failure of the pickup arm is observed or the analyzer stops functioning, contact Tosoh Technical Support for an expedited service visit. " Complete and return the attached Acknowledgement Form by any of the listed methods. " 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: 393
Distribution: Distributed nationwide. Foreign distribution to Canada and Latin America.
Product codes and lots: All units are affected

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0469-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0469-2019	Class II	Terminated	Voluntary: Firm initiated	2018-11-21	2018-11-14

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