Tosoh AIA-900 Analyzer Recalled for Potential Harness Wear
Tosoh Bioscience is recalling 258 AIA-900 Automated Immunoassay Analyzers because internal harnesses may wear prematurely, causing the device to stop functioning and 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 user or patient injuries have been reported. The hazard is a functional failure leading to delayed testing rather than direct physical harm, fitting the criteria for a moderate severity score.
Plain-English summary
Tosoh Bioscience Inc is recalling 258 units of the AIA-900 Automated Immunoassay Analyzer. The recall addresses a potential issue where the mixing motor drive harness and mixing home detection sensor relay harness may rub against the Plarail chain during operation, leading to premature wear. This wear can trigger a "D.lane Mix home overrun" error [4093], causing the analyzer to cease functioning and become unavailable for use.
The affected devices were distributed nationwide and in several foreign countries, including Chile, Colombia, Ecuador, Guatemala, Honduras, Panama, Peru, Puerto Rico, Uruguay, and Venezuela. The recall covers all active analyzer serial numbers. If the sensor relay harness fails, the analyzer will stop working, which may result in a delay in testing and reporting patient test results.
Tosoh is aware of two complaints associated with the unexpected wearing of the harness. There have been no user or patient injuries reported that are related to this device malfunction. Replacement of the motor drive harness and mixing home detection sensor relay harness will mitigate the potential for premature wear and prevent the system error.
The recalled product
- Product
- AIA-900 Automated Immunoassay Analyzer performs three methods of immunoassay: an immunoenzymetric (IEMA) or sandwich immunoassay, a competitive binding (EIA) immunoassay, and a two-step immunoenzymetric immunoassay.
- Manufacturer
- Tosoh Bioscience Inc
- Affected units
- 258
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 active analyzer serial numbers
Distribution
Distributed nationwide across the United States.
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