Tosoh AIA-900 Analyzer Software Issue May Delay Patient Testing
Tosoh is recalling three AIA-900 immunoassay analyzers due to a software issue that may cause reagent data errors, potentially delaying patient 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 the consequence is only a slight delay in testing and that the failure is mitigated by hardware design, with no reported injuries or illnesses.
Plain-English summary
Tosoh Bioscience Inc is recalling three units of the Tosoh AIA-900 immunoassay Analyzer. The recall is due to a software issue that may cause the liquid volume detection entries for the second and third reagent bottles to be overwritten with data from the first reagent bottle.
The affected units were distributed to accounts in Georgia and New York. The specific codes for the affected units are 10313605, 10503612, and 10634103. Tosoh has released software version 2.51 or later to fix the problem, and the hardware design mitigates the failure.
The consequence of this issue would be a slight delay in testing patient samples or reporting patient results. No injuries or illnesses have been reported. Healthcare facilities should contact Tosoh Bioscience Inc to obtain the updated software.
The recalled product
- Product
- Tosoh AIA-900 immunoassay Analyzer
- Manufacturer
- Tosoh Bioscience Inc
- Affected units
- 3
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)
- 10313605 10503612 10634103
Distribution
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