Z-0485-2019Class II

Tosoh AIA-900 immunoassay Analyzer

Name: Z-0485-2019 Tosoh AIA-900 immunoassay Analyzer
Creator: Tosoh Bioscience Inc
Published: 2018-09-28
License: https://open.fda.gov/license/

Tosoh Bioscience Inc / initiated 2018-09-28 / Terminated / root cause: software

FDA source

Tosoh Bioscience Inc began a recall of Tosoh AIA-900 immunoassay Analyzer on 2018-09-28. FDA classified it as Class II and gives the reason as "A software issue may cause the liquid volume detection entries for 2nd and 3rd reagent bottles to be overwritten with the data from the 1st reagent bottle. Tosoh has released software version 2.51 (or later) to fix the...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0485-2019
Classification: Class II
Status: Terminated
Initiated: 2018-09-28
Posted: 2018-11-19
Terminated: 2020-07-08
Recalling firm: Tosoh Bioscience Inc
Product: Tosoh AIA-900 immunoassay Analyzer
Product code: KHO Fluorometer, For Clinical Use
Reason for recall: A software issue may cause the liquid volume detection entries for 2nd and 3rd reagent bottles to be overwritten with the data from the 1st reagent bottle. Tosoh has released software version 2.51 (or later) to fix the problem. This failure is mitigated by the hardware design. The consequence would be a slight delay in testing patient sample or reporting patient result.
Root cause tag: software
FDA root cause: Software design
Action: On September 28, 2018, the firm issued an Urgent Medical Device Recall letter to affected customers. Customers were informed of the software issue. The firm has released software version 2.51 (or later) which corrects the problem. Three analyzers were identified that do not have the most current software version and are at risk for the error: 10313605, 10503612, and 10634103. A field service engineer will be contacting customers with these units in their possession to schedule a service visit in order to upgrade those analyzers to the current version of the operating software. Immediate Actions to be taken by the Customer/User -Thoroughly review the content of this letter. -Complete and return the attached Acknowledgement Form. -File this notice with your laboratory records and forward this information to other supervisors or managers in your laboratory to ensure that they are aware of the potential issue. 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: 3
Distribution: Distributed to accounts in GA and NY.
Product codes and lots: 10313605 10503612 10634103

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0485-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0485-2019	Class II	Terminated	Voluntary: Firm initiated	2018-11-28	2018-11-19

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)