Recall Z-0492-2018 ยท KHO Fluorometer, For Clinical Use
Tosoh Bioscience Inc
TosohSorter 9tray, Product Code 022931and TosohSorter 19tray, Product Code 022932. Product Usage: The AIA-900 9tray Sorter and AIA-900 19tray Sorter supports the automation of the AIA-900 systems.
| Date | Jun 11, 2017 |
| Status | Terminated |
| 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. |
| Root cause | Nonconforming Material/Component |
| Action | Customers were sent a recall notification by email on July 11, 2017 informing them that their local Field Service Engineer would contact them to make arrangements to proactively replace the affected parts. Follow up notifications will be by Federal Express with verification of delivery. |
| Quantity | 565 total devices U.S. |
| Distribution | Worldwide Distribution - U.S. Nationwide - Latin America |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.