Lower riskMedical device recall · FDA · Published September 28, 2018
Tosoh AIA-900 Analyzer Software Issue: Risk of Test Delay
Tosoh recalls AIA-900 immunoassay analyzers due to software issue causing potential test delays. Affected units may need software update to prevent inaccurate results.
A software issue may cause the liquid volume detection entries for 2nd and 3rd reagent bottles to be overwritten with the data from the 1st reagent bottle. Tosoh has released software version 2.51 (or later) to fix the problem. This failure is mitigated by the hardware design. The consequence would be a slight delay in testing patient sample or reporting patient result.
Take action
Contact the company
📍Recalling firmTosoh Bioscience Inc3600 Gantz Rd · Grove City, OH 43123-1895
“Tosoh AIA-900 Analyzer Software Issue: Risk of Test Delay.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69725-tosoh-aia-900-analyzer-software-issue-risk-of-test-delay. Based on FDA recall #Z-0485-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0485-2019%22&limit=1).
The FDA announced on 2018-09-28 that Tosoh Bioscience Inc is recalling three Tosoh AIA-900 immunoassay Analyzers due to a software issue. This defect may cause liquid volume detection entries for reagent bottles to be overwritten, potentially delaying patient testing or result reporting.
Distribution: Distributed to accounts in GA and NY
The hazard
A software issue may cause the liquid volume detection entries for the 2nd and 3rd reagent bottles to be overwritten with data from the 1st reagent bottle. Tosoh has released software version 2.51 (or later) to fix the problem. The consequence would be a slight delay in testing patient samples or reporting patient results.
Context
GovInfoNow's records show Tosoh Bioscience Inc has 19 other recalls on record since 2017-06-11. Other recent recalls of similar products include Beckman Coulter AU5800 Chemistry Analyzer Recall (2026-01-30), AU480 Chemistry Analyzer May Show Error Message Causing Delay in Patient Results (2026-08-03), and Roche Elecsys Anti-TSHR Assay Recall (2025-11-21).
How to tell if you have this one
Check your Tosoh AIA-900 analyzer's serial number against 10313605, 10503612, or 10634103. The device is sold as an immunoassay analyzer for medical testing.
Brand
Tosoh
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Update Software
Install software version 2.51 or later to fix the data overwrite issue.
Where it went and when
Where it was distributed
Distributed in Georgia and New York.
Listed by the agency
Not listed
FDA distribution: “Distributed to accounts in GA and NY.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Georgia, New York.
Recall timeline
FDA terminated this recall 21 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-0485-2019 (September 28, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0485-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 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.