Reported Mar 11, 2020 · Terminated

AIA-360 Automated Immunoassay Analyzer, Product Code 019945

Tosoh Bioscience Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Tosoh Bioscience Inc · 3600 Gantz Rd · Grove City, OH · 43123-1895

Is this the product you have?

    • AIA-360 Automated Immunoassay Analyzer
    • Product Code 019945
Lot codes and dates
    • 28469102
    • 28629205
    • 28469202
    • 28629305
    • 28469302
    • 28629405
    • 28469402
    • 28629505
    • 28469502
    • 28629605
    • 28469602
    • 28629705
    • 28469702
    • 28709907
    • 28469802
    • 28719007
    • 28469902
    • 28719107
    • 28479002
    • 28719207
    • 28519303
    • 28719307
    • 28519403
    • 28719407
    • 28519503
    • 28719507
    • 28519603
    • 28719607
    • 28519703
    • 28719707
    • 28519803
    • 28719807
    • 28519903
    • 28719907
    • 28529003
    • 28729007
    • 28529103
    • 28729108
    • 28529203
    • 28729208
    • 28529903
    • 28729308
    • 28539003
    • 28729408
    • 28539103
    • 28729508
    • 28539203
    • 28729608
    • 28539303
    • 28759908
    • 28539403
    • 28769008
    • 28539503
    • 28769108
    • 28539603
    • 28769208
    • 28539703
    • 28769308
    • 28539803
    • 28769408
Amount recalled
12

Where it was sold

Why it was recalled

A display screen software issue on the analyzer causes the display to freeze when display screen is touched at the same time as a command from the instrument firmware, causing the instrument to stop. As a result, the run is aborted and the results are not retrievable.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Sep 10, 2020 · Data as of Sep 19, 6:52 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.