The Recall Desk
ModerateFDA (Devices)·Z-0492-2018·Announced 2018-02-07

Tosoh AIA-900 Sorters Recalled for Potential Photo Interrupter Malfunction

Tosoh Bioscience Inc is recalling AIA-900 9tray and 19tray Sorters due to a potential malfunction of the photo interrupter caused by aging.

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. The source text describes a potential malfunction due to aging without reporting any injuries, illnesses, or specific adverse health consequences, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Tosoh Bioscience Inc is recalling the Tosoh Sorter 9tray (Product Code 022931) and Tosoh Sorter 19tray (Product Code 022932). These devices are used to support the automation of AIA-900 systems. The recall covers 565 total devices distributed in the United States and Latin America.

The recall was initiated due to a potential malfunction of the photo interrupter (PI). This potential malfunction has been attributed to aging and premature deterioration of the PI collector current. The affected units include the AIA-900 19tray Sorter with serial numbers 10000109 to 80136909 and the AIA-900 9tray Sorter with serial numbers 10000109 to 10707402.

No specific instructions for consumers are provided in the source text. Users of these devices should verify their serial numbers against the affected ranges listed above.

The recalled product

Product
Tosoh¿Sorter 9tray, Product Code 022931and Tosoh¿Sorter 19tray, Product Code 022932. Product Usage: The AIA-900 9tray Sorter and AIA-900 19tray Sorter supports the automation of the AIA-900 systems.
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.

See all 2 products in this recall →