Recall Z-0492-2018— Tosoh Bioscience Inc
Class II · Terminated
Class II FDA medical device recall by Tosoh Bioscience Inc, initiated 2017-06-11, terminated 2019-12-31. FDA's recall record names no specific 510(k) clearance for this event. 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: 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..
- Recalling firm
- Tosoh Bioscience Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-06-11
- Terminated
- 2019-12-31
- Firm location
- Grove City, OH, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.