Recall Z-0492-2018
Tosoh Bioscience Inc · initiated June 11, 2017
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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.
Codes / lots: AIA-900 19tray Sorter with S/N 10000109 to S/N 80136909. AIA-900 9tray Sorter with S/N 10000109 to S/N 10707402.
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.
FDA-determined cause: Nonconforming Material/Component
Action taken
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.
Details
- Recall number
- Z-0492-2018
- Initiated
- June 11, 2017
- Terminated
- December 31, 2019
- Product code
- KHO – Fluorometer, For Clinical Use
- Quantity
- 565 total devices U.S.
- Distribution
- Worldwide Distribution - U.S. Nationwide - Latin America
- Recalling firm
- Tosoh Bioscience Inc, Grove City, OH
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0491-2018 Class II | TosohAutomated Enzyme Immunoassay Analyzer AIA-900, Product Catalog No. 022930. Product…This recall has been initiated due to a potential malfunction of the photo interrupter (Pl). The potential… | 06/11/2017Terminated |