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Terminated

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.

FDA Recall Z-0492-2018 · Posted None

Recalling FirmTosoh Bioscience Inc
Recall StatusTerminated
Product CodeKHO
Date Initiated2017-06-11
Date Terminated2019-12-31
Product Quantity565 total devices U.S.

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.

Firm 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.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Worldwide Distribution - U.S. Nationwide - Latin America

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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