Tosoh AIA-360 Analyzer Recalled Due to Display Screen Software Freeze
Tosoh Bioscience Inc is recalling 12 AIA-360 Automated Immunoassay Analyzers because a software issue causes the display to freeze and stop the instrument.
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. The hazard involves a software malfunction that stops the instrument and prevents result retrieval, but the source text does not report any injuries, illnesses, or deaths, fitting the criteria for a moderate severity recall.
Plain-English summary
Tosoh Bioscience Inc is recalling 12 units of the AIA-360 Automated Immunoassay Analyzer (Product Code 019945). The recall is due to a display screen software issue that causes the display to freeze when the screen is touched simultaneously with a command from the instrument firmware. This malfunction causes the instrument to stop, resulting in aborted runs and unretrievable results.
The affected units were distributed to Arizona, Nebraska, New Jersey, New York, and Washington. Foreign distribution included the Cayman Islands, Costa Rica, and Uruguay. Specific serial numbers for the affected units are listed in the agency's recall record.
Consumers and healthcare facilities should stop using the affected analyzers and contact Tosoh Bioscience Inc for further instructions on the recall.
The recalled product
- Product
- AIA-360 Automated Immunoassay Analyzer, Product Code 019945
- Manufacturer
- Tosoh Bioscience Inc
- Affected units
- 12
Distribution
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