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Recall Observatory FDA recall evidence

Device 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.

Z-0492-2018

June 11, 2017

Class II

Product summary

Firm
Tosoh Bioscience Inc
Event
Event 78776
Status
Terminated
Classification
Class II
Quantity
565 total devices U.S.
Official record key
device-enforcement:Z-0492-2018

Official wording

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.

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.

Distribution pattern: Worldwide Distribution - U.S. Nationwide - Latin America

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.

Field note

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