Lower riskMedical device recall · FDA · Published January 10, 2020
Tosoh AIA-360 Analyzer Software Issue: Display Freezes During Use
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.
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📍Recalling firmTosoh Bioscience Inc3600 Gantz Rd · Grove City, OH 43123-1895
✎ GovInfoNow plain-language explainer
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. Read more at govinfonow.com/recall/66112-tosoh-aia-360-analyzer-software-issue-display-freezes-during-use.
“Tosoh AIA-360 Analyzer Software Issue: Display Freezes During Use.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/66112-tosoh-aia-360-analyzer-software-issue-display-freezes-during-use. Based on FDA recall #Z-1420-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1420-2020%22&limit=1).
The FDA announced on Jan. 10, 2020, that Tosoh Bioscience Inc is recalling the AIA-360 Automated Immunoassay Analyzer due to a display screen software issue. The hazard causes the instrument to stop and aborts runs, making results unretrievable.
Distribution: AZ, NE, NJ, NY, WA, Cayman Islands, Costa Rica, Uruguay
The hazard
A display screen software issue causes the analyzer's display to freeze when touched simultaneously with a firmware command. This stops the instrument, aborts the run, and prevents retrieval of results.
Context
GovInfoNow's records show Tosoh Bioscience Inc has 19 other recalls on record since June 11, 2017. Other recent recalls of similar products include Tosoh ST AIA-Pack Testosterone Recall (June 12, 2026) and Tosoh AIA-Pack BHCG Calibrator Recall (Aug. 7, 2020). AU480 Chemistry Analyzer May Show Error Message Causing Delay in Patient Results was reported on Aug. 3, 2026.
How to tell if you have this one
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.
Brand
Tosoh Bioscience
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Device Status
Verify if the display freezes when touched during command execution.
Where it went and when
Where it was distributed
Distributed in 5 states, and outside the U.S.
Listed by the agency
Not listed
FDA distribution: “Distributed to AZ, NE, NJ, NY, and WA. Foreign distribution to Cayman Islands, Costa Rica, and Uruguay” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Arizona, Nebraska, New Jersey, New York, Washington.
Recall timeline
FDA terminated this recall 8 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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.
Official source: FDA Recall #Z-1420-2020 (January 10, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1420-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.