Z-0602-2019Class II

AIA-900 Automated Immunoassay Analyzer performs three methods of immunoassay: an immunoenzymetric (IEMA) or...

Name: Z-0602-2019 AIA-900 Automated Immunoassay Analyzer performs three methods of immunoassay: an immunoenzymetric (IEMA) or...
Creator: Tosoh Bioscience Inc
Published: 2017-09-28
License: https://open.fda.gov/license/

Tosoh Bioscience Inc / initiated 2017-09-28 / Terminated / root cause: design

FDA source

Tosoh Bioscience Inc began a recall of AIA-900 Automated Immunoassay Analyzer performs three methods of immunoassay: an immunoenzymetric (IEMA) or sandwich immunoassay, a competitive binding (EIA)... on 2017-09-28. FDA classified it as Class II and gives the reason as "The firm has become aware of a potential issue that may affect the mixing motor drive harness and mixing home detection sensor relay harness on your AIA-900 Analyzer. It is possible that the harnesses could rub against...". 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-0602-2019
Classification: Class II
Status: Terminated
Initiated: 2017-09-28
Posted: 2018-12-13
Terminated: 2020-12-08
Recalling firm: Tosoh Bioscience Inc
Product: AIA-900 Automated Immunoassay Analyzer performs three methods of immunoassay: an immunoenzymetric (IEMA) or sandwich immunoassay, a competitive binding (EIA) immunoassay, and a two-step immunoenzymetric immunoassay.
Product code: KHO Fluorometer, For Clinical Use
Reason for recall: The firm has become aware of a potential issue that may affect the mixing motor drive harness and mixing home detection sensor relay harness on your AIA-900 Analyzer. It is possible that the harnesses could rub against the Plarail chain during operation and result in premature wear. If observed, this issue will cause the following system error to be reported D.lane Mix home overrun error [4093] . If observed, this issue will cause the AIA-900 Analyzer not to function and the D.lane Mix home overrun error [4093] will be reported by the system. Replacement of the motor drive harness and mixing home detection sensor relay harness will mitigate the potential for premature wear and effectively prevent this issue from causing the system error. If the sensor relay harness fails, the AIA-900 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 is aware of two complaints associated with the unexpected wearing of the harness. There have been no user or patient injuries reported that are related to this device malfunction.
Root cause tag: design
FDA root cause: Component design/selection
Action: On September 28, 2018, the firm notified customers via Urgent Medical Device Recall letter. Customers were informed of the potential issue. Immediate Actions to be taken by the Customer: Thoroughly review the content of this letter. " Identify if the serial number of your analyzer is listed in this notification. o If the serial number of your analyzer is listed: 1. At the next service call or scheduled PM, whichever occurs first, a Tosoh field service engineer will verify the motor drive harness and mixing home detection sensor relay harness are bundled together and placed into a double-coated cable or repair the harness bundle as applicable. 2. Complete and return the attached Acknowledgement Form by any of the listed methods. o If the serial number of your analyzer is not listed: 1. Tosoh records indicate that the harness bundle on your instrument(s) has already been replaced. 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 other supervisors or managers in your laboratory to ensure that they are aware of the potential issue.
Quantity in commerce: 258
Distribution: Nationwide distribution. Foreign distribution to Chile, Colombia, Ecuador, Guatemala, Honduras, Panama, Peru, Puerto Rico, Uruguay, and Venezuela.
Product codes and lots: All active analyzer serial numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0602-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0602-2019	Class II	Terminated	Voluntary: Firm initiated	2018-12-19	2018-12-13

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)