FDA-Device2018-02-07Class II

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.

Tosoh Bioscience Inc
Hazard

This recall has been initiated due to a potential malfunction of the photo interrupter (Pl). The potential malfunction has been attributed to aging and premature deterioration of the Pl collector current.

Sold states
Worldwide Distribution - U.S. Nationwide - Latin America
Affected count
565 total devices U.S.
Manufactured in
3600 Gantz Rd, Grove City, OH, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0492-2018

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