Tosoh AIA-360 Analyzer Recalled for Table Home Sensor Malfunction
Tosoh Bioscience Inc is recalling 438 AIA-360 Analyzers because a table home sensor malfunction can cause the device to stop functioning, potentially delaying patient test results.
What this means for you
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, but the source explicitly states that no serious injuries have been reported and the primary hazard is a delay in testing rather than direct physical harm, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Tosoh Bioscience Inc is recalling 438 units of the AIA-360 Analyzer due to a potential issue with the table home sensor. The AIA-360 is a medical device used to perform immunoassays, including immunoenzymetric and competitive binding methods. The recall affects all units with serial numbers prior to "1701". The devices were distributed nationwide and internationally to Honduras, the Caribbean, Chile, Colombia, Costa Rica, Uruguay, Ecuador, Panama, Mexico, Canada, and Venezuela.
The table home sensor may fail to detect the table home position. If this malfunction occurs, the sensor board may need to be replaced, and the AIA-360 analyzer will cease to function and become unavailable for use. This failure may result in a delay in testing and reporting patient test results. Tosoh has received three complaints related to this issue, with no serious injuries reported.
Healthcare facilities should stop using the affected AIA-360 Analyzers and contact Tosoh Bioscience Inc for instructions on replacing the sensor board or the unit. Users should verify their device serial numbers to determine if they are affected by this recall.
The recalled product
- Product
- AIA-360 Analyzer is capable of performing two methods of immunoassay: an immunoenzymetric (IEMA) or sandwich immunoassay, a competitive binding (EIA) immunoassay. An antigen-antibody reaction begins by combining a patient sample, control, or calibrator with a diluent in an immuno
- Manufacturer
- Tosoh Bioscience Inc
- Affected units
- 438
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All units with serial numbers prior to "1701"
Distribution
Distributed nationwide across the United States.
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