The Recall Desk

FDA (Devices) recall action 78776

Tosoh Bioscience Inc recalled 2 products on 2018-02-07

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2018-02-07
Critical
0
Units
1,130

Why these products were recalled

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.

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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–2 of 2

  • ModerateFDA (Devices)··2018-02-07

    Tosoh AIA-900 Analyzer Recalled for Photo Interrupter Malfunction

    Tosoh Bioscience Inc is recalling 565 AIA-900 Automated Enzyme Immunoassay Analyzers due to a potential malfunction of the photo interrupter caused by aging.

    Product
    Tosoh¿Automated Enzyme Immunoassay Analyzer AIA-900, Product Catalog No. 022930. Product Usage: The AIA-900 Automated Enzyme Immunoassay System is an automated analyzer for in vitro diagnostic use that measures a variety of substances in serum, plasma, and or urine using the AI
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2018-02-07

    Tosoh AIA-900 Sorters Recalled for Potential Photo Interrupter Malfunction

    Tosoh Bioscience Inc is recalling AIA-900 9tray and 19tray Sorters due to a potential malfunction of the photo interrupter caused by aging.

    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.
    Category
    Distribution
    0 states