Tosoh AIA-900 Analyzer: Harness Wear Risk May Cause System Errors
Tosoh recalls AIA-900 analyzers with potential harness wear causing system errors. Affected units may show error code 4093 and stop functioning. No injuries reported.
Use caution until it’s fixed
The firm has become aware of a potential issue that may affect the mixing motor drive harness and mixing home detection sensor relay harness on your AIA-900 Analyzer. It is possible that the harnesses could rub against the Plarail chain during operation and result in premature wear. If observed, this issue will cause the following system error to be reported D.lane Mix home overrun error [4093] . If observed, this issue will cause the AIA-900 Analyzer not to function and the D.lane Mix home overrun error [4093] will be reported by the system. Replacement of the motor drive harness and mixing home detection sensor relay harness will mitigate the potential for premature wear and effectively prevent this issue from causing the system error. If the sensor relay harness fails, the AIA-900 analyzer will cease to function and will be unavailable for use. If this issue occurs, there may be a delay in testing and reporting patient test results. Tosoh is aware of two complaints associated with the unexpected wearing of the harness. There have been no user or patient injuries reported that are related to this device malfunction.
Contact the company
What happened, in plain English
Tosoh is recalling AIA-900 Automated Immunoassay Analyzers due to a risk that harnesses could wear prematurely, causing system errors and stopping the device from working. This could delay patient test results if the issue occurs. Read more at govinfonow.com/recall/72939-tosoh-aia-900-analyzer-harness-wear-risk-may-cause-system.
Source Summary by GovInfoNow · govinfonow.com/recall/72939-tosoh-aia-900-analyzer-harness-wear-risk-may-cause-system · Updated September 17, 2026 · FDA enforcement record: FDA #Z-0602-2019
Cite this page
“Tosoh AIA-900 Analyzer: Harness Wear Risk May Cause System Errors.” GovInfoNow, updated September 17, 2026. https://govinfonow.com/recall/72939-tosoh-aia-900-analyzer-harness-wear-risk-may-cause-system. Based on FDA recall #Z-0602-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0602-2019%22&limit=1).
Why it’s dangerous
The mixing motor drive harness and mixing home detection sensor relay harness could rub against the Plarail chain during operation, causing premature wear. This may lead to system error code 4093 and prevent the analyzer from functioning, delaying patient test results.
Who’s affected
Healthcare facilities using the AIA-900 analyzer are most at risk, as the device is used for patient testing. The issue affects specific serial numbers that have been identified.
How to tell if you have this one
Check if your AIA-900 analyzer has an active serial number listed in the recall notice. The issue has been reported in two specific cases but no exact model numbers are provided.
- Brand
Tosoh- Category
Medical device
What to do — step by step
Check for Error Code 4093
If your analyzer displays error code 4093, it may be affected by the harness wear issue.
Contact Tosoh for Replacement Parts
Tosoh will provide replacement harnesses to fix the issue if you have the affected serial numbers.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Nationwide distribution. Foreign distribution to Chile, Colombia, Ecuador, Guatemala, Honduras, Panama, Peru, Puerto Rico, Uruguay, and Venezuela.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 3.2 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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-0602-2019 (September 28, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0602-2019 to see it in context.
- Plain-language summary written by qwen3:4b on September 17, 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.