Tosoh Bioscience Inc: Medical Device Recall in 2018 - (Recall #: Z-0600-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: September 28, 2018

Date Posted: December 19, 2018

Recall Number: Z-0600-2019

Event ID: 81190

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.

Status: Terminated

Product Quantity: 395

Code Information:

Affects all active analyzers. 022930, 022930R

Distribution Pattern:

US Nationwide distribution and International distribution to Colombia, Chile, Honduras, Cayman Islands, Panama, Costa Rica, Guatemala, Venezuela, Uruguay, Peru, and Ecuador.

Voluntary or Mandated:

Voluntary: Firm initiated