Z-0492-2018 Class II Terminated
FDA device recall Z-0492-2018 was initiated by Tosoh Bioscience Inc on June 11, 2017 and is designated Class II. 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 cur… The recall status is terminated (terminated December 31, 2019). Affected quantity: 565 total devices U.S..
Recall Details
- Product Type
- Devices
- Report Date
- February 7, 2018
- Initiation Date
- June 11, 2017
- Termination Date
- December 31, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 565 total devices U.S.
Product Description
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 Pattern
Worldwide Distribution - U.S. Nationwide - Latin America
Code Information
AIA-900 19tray Sorter with S/N 10000109 to S/N 80136909. AIA-900 9tray Sorter with S/N 10000109 to S/N 10707402.