Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0613-2019·Announced 2018-12-26

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.

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, 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…
Manufacturer: Tosoh Bioscience Inc
Category: Medical Device — In Vitro Diagnostics
Hazard: device-malfunction
delayed-diagnosis
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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