FDA recall Z-0492-2018

Tosoh Bioscience Inc · Class II · device

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.

Reason for recall

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.

Distribution

Worldwide Distribution - U.S. Nationwide - Latin America

Key facts

Status
Terminated
Initiation date
2017-06-11
Report date
2018-02-07
Termination date
2019-12-31
Voluntary/Mandated
Voluntary: Firm initiated
Location
Grove City, OH, United States

Primary source

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