Tosoh AIA-900 Analyzer Recalled for Potential Drive Motor Failure
Tosoh Bioscience is recalling 247 AIA-900 Automated Immunoassay Analyzers due to a potential drive motor defect that may cause the device to stop functioning and delay patient test results.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source explicitly states that no serious injuries have been reported. The primary risk is a delay in patient test results due to device malfunction, which fits the criteria for a moderate severity recall involving a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Tosoh Bioscience is recalling 247 units of the AIA-900 Automated Immunoassay Analyzer, product codes 022930 and 022930R. The recall addresses a potential issue with the axis base of the turntable rotation drive motor. If the tension of the timing belt between the turntable rotation pulley and the drive motor is not adjusted correctly, it can increase lateral load on the motor axis, leading to inclination and damage of the motor axis.
The affected units were distributed worldwide, including nationwide in the United States in Florida, Maryland, Nevada, New York, South Carolina, and Texas, as well as in the Cayman Islands, Chile, Colombia, Dominican Republic, Ecuador, Guatemala, Honduras, Peru, Puerto Rico, Uruguay, and Venezuela. Specific serial numbers are listed in the recall documentation. Tosoh has been inspecting the timing belt tension during scheduled preventative maintenance visits since January 12, 2017, and correcting analyzers where the issue was observed.
If the drive motor fails, the AIA-900 analyzer will cease to function and be unavailable for use, which may result in delays in testing and reporting patient test results. Tosoh has received five complaints related to this issue, with no serious injuries reported. Healthcare facilities should contact Tosoh Bioscience for further instructions on inspection and correction of the affected devices.
The recalled product
- Product
- AIA-900 Automated Immunoassay Analyzer, product code 022930 /022930R Product Usage: The AIA-900 is capable of performing three methods of immunoassay: an immunoenzymetric (IEMA) or sandwich immunoassay, a competitive binding (EIA) immunoassay, and a two-step immunoenzymetric…
- Manufacturer
- Tosoh Bioscience Inc
- Affected units
- 247
Distribution
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