Tosoh AIA-2000 and AIA-900 Analyzers Recalled for Incubator Slippage
Tosoh Bioscience is recalling AIA-2000 and AIA-900 analyzers because a timing belt issue can cause incubator slippage, leading to 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 hazard is a mechanical error causing delays rather than direct physical harm, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Tosoh Bioscience Inc is recalling 95 units of the AIA-2000 and AIA-900 analyzers due to a potential mechanical issue. The recall affects product codes 022100, 022100R, 022101, and 022101R. The devices were distributed nationwide in the United States and internationally to Colombia, Chile, Honduras, Cayman Islands, Panama, Costa Rica, Guatemala, Venezuela, Uruguay, Peru, and Ecuador.
The recall is being conducted because the tension of the timing belt may not be adjusted correctly, which can result in misalignment and slippage of the incubator unit. If this slippage occurs, the unit will cease to function and report a system error. This malfunction may cause 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.
There have been no reports of injury related to this issue. The recall is classified as Class II by the FDA.
The recalled product
- Product
- AIA-2000 Analyzer, Product code 022100, 022100R, 022101, 022101R 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…
- Manufacturer
- Tosoh Bioscience Inc
- Affected units
- 95
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 (4)
- Affects all active analyzers. 022100
- 022100R
- 022101
- 022101R
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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