Tosoh AIA-900 Analyzer Recalled for Photo Interrupter Malfunction
Tosoh Bioscience Inc is recalling 565 AIA-900 Automated Enzyme Immunoassay Analyzers due to a potential malfunction of the photo interrupter caused by aging.
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, which typically indicates a situation where use of the product could cause temporary or medically reversible health consequences. The source text describes a potential malfunction due to aging but does not report specific injuries, illnesses, or deaths, aligning with a moderate severity assessment for a diagnostic device component issue.
Plain-English summary
Tosoh Bioscience Inc is recalling the Tosoh Automated Enzyme Immunoassay Analyzer AIA-900, Product Catalog No. 022930. The recall involves 565 total devices in the United States. The affected devices are distributed worldwide, including nationwide in the U.S. and in Latin America.
The recall was initiated due to a potential malfunction of the photo interrupter (PI). This malfunction is attributed to aging and premature deterioration of the PI collector current. The recall covers all photo interrupter sensors currently in AIA-900 analyzers with serial numbers ranging from 10000103 to 11147003.
The AIA-900 is an automated analyzer used for in vitro diagnostic purposes to measure various substances in serum, plasma, and urine using the AIA-PACK reagent series. Users should check their device serial numbers to determine if they are affected by this recall.
The recalled product
- Product
- Tosoh¿Automated Enzyme Immunoassay Analyzer AIA-900, Product Catalog No. 022930. Product Usage: The AIA-900 Automated Enzyme Immunoassay System is an automated analyzer for in vitro diagnostic use that measures a variety of substances in serum, plasma, and or urine using the…
- Manufacturer
- Tosoh Bioscience Inc
- Hazard
- Affected units
- 565
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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