Tosoh AIA-900 and AIA-2000 Analyzers Recalled for Incubator Slippage Risk
Tosoh Bioscience is recalling AIA-900 and AIA-2000 analyzers due to a potential incubator slippage issue that may cause system errors and delays in 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 there have been no reports of injury and the primary risk is a delay in testing rather than direct physical harm, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Tosoh Bioscience Inc is recalling 395 units of the AIA-900 and AIA-2000 analyzers, product codes 022930 and 022930R. These devices are used to perform various immunoassay methods, including immunoenzymetric and competitive binding assays. The recall affects all active analyzers with these product codes.
The recall is due to a potential issue where the incubator unit within the system may slip if the tension of the timing belt is not adjusted correctly. This misalignment can result in a mechanical error. If incubator slippage occurs, the unit will cease to function and report a system error, which may lead to delays in testing and reporting patient test results. Tosoh has taken actions to inspect the timing belt tension during preventative maintenance and correct instruments where the issue has been observed.
The affected units were distributed nationwide in the United States and internationally to Colombia, Chile, Honduras, Cayman Islands, Panama, Costa Rica, Guatemala, Venezuela, Uruguay, Peru, and Ecuador. There have been no reports of injury related to this issue. Users should contact Tosoh Bioscience for further instructions on inspection and correction.
The recalled product
- 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…
- Manufacturer
- Tosoh Bioscience Inc
- Affected units
- 395
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 (2)
- Affects all active analyzers. 022930
- 022930R
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Tosoh Bioscience Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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