Z-0600-2019Class II

AIA-900Analyzer, Product code 022930, 022930R The AIA-2000 analyzer and AIA-900 analyzer are capable of...

Name: Z-0600-2019 AIA-900Analyzer, Product code 022930, 022930R The AIA-2000 analyzer and AIA-900 analyzer are capable of...
Creator: Tosoh Bioscience Inc
Published: 2018-09-28
License: https://open.fda.gov/license/

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

FDA source

Tosoh Bioscience Inc began a recall of AIA-900Analyzer, Product code 022930, 022930R The AIA-2000 analyzer and AIA-900 analyzer are capable of performing three methods of immunoassay: an... on 2018-09-28. FDA classified it as Class II and gives the reason as "Tosoh Bioscience has become aware of a potential issue with the AIA-900 and AIA-2000 analyzers that could result in slippage of the incubator unit contained within the system. If the tension of the timing belt is not...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0600-2019
Classification: Class II
Status: Terminated
Initiated: 2018-09-28
Posted: 2018-12-13
Terminated: 2020-09-03
Recalling firm: Tosoh Bioscience Inc
Product: AIA-900Analyzer, Product code 022930, 022930R The AIA-2000 analyzer and AIA-900 analyzer are capable of performing 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: Tosoh Bioscience has become aware of a potential issue with the AIA-900 and AIA-2000 analyzers that could result in slippage of the incubator unit contained within the system. If the tension of the timing belt is not adjusted correctly, it is possible for a misalignment that will result in a mechanical error. Tosoh has taken the required actions to inspect the tension of the timing belt during preventative maintenance and correct the instruments where this issue has been observed. If incubator slippage occurs, the unit will cease to function, and a system error will be reported. If this occurs, there may be a delay in testing and reporting patient test results. There have been no reports of injury related to this issue.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On September 28, 2018, the firm, Tosoh Bioscience, notified consignees via an "URGENT: MEDICAL DEVICE RECALL" letter. The letter described the product, problem and actions to be taken. The letter informed customers that the AIA-900 and AIA -2000 analyzers had a potential issue that could result in slippage of the incubator unit within the system. Immediate Actions to be taken by the Customer/User " Thoroughly review the content of this letter. " Continue to use your Instrument. o Contact Tosoh Technical Support if mechanical errors occur. o The tension of the timing belt will be assessed and adjusted as needed at the next scheduled preventive maintenance visit. " Complete and return the attached Acknowledgement Form via Fax to: 1-605-636-8651; email: [email protected] or mail to: Recall Coordinator, Tosoh Bioscience, Inc., 3600 Gantz Road, Grove City, OH 43123. " 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 call (800) 248-6764 or email: [email protected] Monday - Friday, from 9:00 AM to 5:00 PM (PST).
Quantity in commerce: 395
Distribution: US Nationwide distribution and International distribution to Colombia, Chile, Honduras, Cayman Islands, Panama, Costa Rica, Guatemala, Venezuela, Uruguay, Peru, and Ecuador.
Product codes and lots: Affects all active analyzers. 022930, 022930R

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0600-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0599-2019	Class II	Terminated	Voluntary: Firm initiated	2018-12-19	2018-12-13
Z-0600-2019	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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)