Z-0475-2019Class II

AIA-2000 Analyzer, Model Nos. AIA-2000LA, AIA-2000ST -

Name: Z-0475-2019 AIA-2000 Analyzer, Model Nos. AIA-2000LA, AIA-2000ST -
Creator: Tosoh Bioscience Inc
Published: 2018-09-28
License: https://open.fda.gov/license/

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

FDA source

Tosoh Bioscience Inc began a recall of AIA-2000 Analyzer, Model Nos. AIA-2000LA, AIA-2000ST - Product Usage: The AIA-2000 is capable of performing three methods of immunoassay: an immunoenzymetric... on 2018-09-28. FDA classified it as Class II and gives the reason as "There is a possibility that the liquid suction pump on some AIA-2000 analyzers may not perform as intended and cause an insufficient volume of wash solution to be removed during the washing step. Incomplete washing of...". 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-0475-2019
Classification: Class II
Status: Terminated
Initiated: 2018-09-28
Posted: 2018-11-16
Terminated: 2020-05-29
Recalling firm: Tosoh Bioscience Inc
Product: AIA-2000 Analyzer, Model Nos. AIA-2000LA, AIA-2000ST - Product Usage: The AIA-2000 is capable of performing three methods of immunoassay: an immunoenzymetric (IEMA) or sandwich immunoassay, a competitive binding (EIA) immunoassay, and a two-step immunoenzymetric 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: There is a possibility that the liquid suction pump on some AIA-2000 analyzers may not perform as intended and cause an insufficient volume of wash solution to be removed during the washing step. Incomplete washing of the sample may result in falsely elevated test results for the sandwich assays and falsely decreased test results for the competitive binding assays. Insufficient washing is detectable through review of the calibration data and QC trending. For example, if incomplete washing occurs, the reported values for the zero- calibration rate will be above the acceptance range. The calibration value may shift and the instrument will not calibrate successfully. If this issue occurs, there may be a delay in testing and reporting patient test results. There have been no user or patient injuries reported related to this issue.
Root cause tag: design
FDA root cause: Component design/selection
Action: On September 28, 2018, the firm distributed Urgent Medical Device Recall letters to affected customers. Customers were informed of the possibility that the liquid suction pump on some AIA-2000 analyzers may not perform as intended and cause an insufficient volume of wash solution to be removed during the washing step. Tosoh has taken the required actions to inspect the liquid suction pump during preventative maintenance and correct the instruments where this issue has been observed. Immediate Actions to be taken by the Customer/User " Thoroughly review the content of this letter. If additional information is needed, please contact Tosoh Technical Support. " Continue using your instrument. o If there is an unexplained rise in the calibration rate and the AIA-2000 Analyzer serial number is listed above, please contact Tosoh Technical Support. o If the assay calibration is as expected, then at the next scheduled Preventive Maintenance (PM) visit, a Tosoh field service engineer will inspect the liquid suction pump and replace it as needed. " File this notice with your laboratory records and forward this information to others in your laboratory. " Complete and return the attached Acknowledgement Form by any of the listed methods. 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: 7
Distribution: US Nationwide distribution in the states of Florida, Kentucky, Maryland, Ohio, Pennsylvania, and Texas.
Product codes and lots: Serial Nos. 10038409, 10038509, 10048009R, 10058011, 10069507, 80018112, 80039511

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0475-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0475-2019	Class II	Terminated	Voluntary: Firm initiated	2018-11-28	2018-11-16

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)