Tosoh AIA-360 Analyzer Recalled for Labeling Clarifications on Maintenance Requirements
Tosoh Bioscience is recalling 1,228 AIA-360 Analyzers to update labeling and training materials regarding maintenance and reagent requirements.
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 and involves labeling changes to clarify maintenance requirements to prevent potential performance issues or contamination, fitting the criteria for moderate severity.
Plain-English summary
Tosoh Bioscience Inc is recalling 1,228 units of the AIA-360 Analyzer, product code 019945/019945R. The recall involves changes to the Tosoh Quick Reference Guide, Training Manual, and Training DVD to align them with the Operators Manual. The devices are distributed in the United States and several countries in North and South America.
The labeling changes clarify specific maintenance requirements, including that the B/F probe must be maintained by a Tosoh field service representative, the use of 70% Ethanol during daily shutdown, and the use of CAP Class 1 reagent grade water for dilution and reconstitution. The firm states that failure to follow these requirements may negatively affect system performance, lead to corrosion of instrument components, or result in bacterial contamination.
No specific instructions for consumers are provided in the source text beyond the implementation of the new labeling changes.
The recalled product
- Product
- AIA-360 Analyzer, product code 019945/019945R The Tosoh AIA-360 Automated Immunoassay Analyzer is for use in vitro diagnostic to provide testing for a broad menu of assays in a unique patented dry reagent format.
- Manufacturer
- Tosoh Bioscience Inc
- Affected units
- 1,228
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)
- Change to labeling affects all devices.
Distribution
Distributed nationwide across the United States.
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