Tosoh Bioscience recalls AIA-360 Automated Immunoassay Analyzers with software issue causing display freezes when touched during command execution, leading to aborted runs and unretrievable results.
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.
Tosoh Bioscience is recalling AIA-360 Automated Immunoassay Analyzers due to a software issue that causes the display to freeze when touched while the instrument is processing commands. This results in test runs being aborted and results being unrecoverable. The issue does not pose a physical safety risk but affects test accuracy.
The software issue causes the display screen to freeze when touched simultaneously with a command from the instrument's firmware. This interruption stops the test run, making results unretrievable. The problem does not involve physical hazards like fire or injury but impacts test accuracy.
Users of the AIA-360 Automated Immunoassay Analyzer with Product Code 019945 are affected. Laboratory staff and healthcare professionals using this device for medical testing are most at risk of inaccurate results.
Check for the AIA-360 Automated Immunoassay Analyzer with Product Code 019945. The device was sold with specific serial numbers listed in the recall notice.
Verify if the display freezes when touched during command execution.
No, the recall does not pose a health risk. The issue affects test results but does not cause injury or physical harm.
Check for the AIA-360 Automated Immunoassay Analyzer with Product Code 019945 listed in the recall notice.
The recall does not provide a remedy, so users should check if the display freezes when touched during command execution.
We’ve drafted a message you can send Tosoh Bioscience to request your refund or repair — edit it as you like.
Subject: Recall Z-1420-2020 — Tosoh Bioscience Tosoh Bioscience Hello, I own a Tosoh Bioscience that is covered by recall Z-1420-2020 from Tosoh Bioscience. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
