Use caution Medical device recall · FDA · Published October 5, 2018

Tosoh AIA-900 Analyzer Recall: Timing Belt Issue May Cause Motor Damage

Tosoh recalls AIA-900 analyzers with potential timing belt misalignment causing motor damage. Five complaints reported with no serious injuries. Affected units include specific serial numbers.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0509-2019Medical device Tosoh Bioscience ›

Use caution until it’s fixed

Tosoh Bioscience has become aware of a potential issue with the axis base of the turntable rotation drive motor on the AIA-900 Analyzer. If the tension of the timing belt between the turntable rotation pulley and drive motor is not adjusted correctly, it is possible to increase the lateral load on the motor axis resulting in the inclination and damage of the motor axis. Since January 12, 2017, Tosoh has been inspecting the tension of the timing belt during scheduled preventative maintenance visit and correcting the analyzers where this issue has been observed. If the drive motor 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 has received five (5) complaints related to this issue with no serious injuries reported.

Take action

Contact the company

Recalling firmTosoh Bioscience Inc3600 Gantz Rd · Grove City, OH 43123-1895

✎ GovInfoNow plain-language explainer

Tosoh is recalling AIA-900 Automated Immunoassay Analyzers that may have timing belt tension issues causing motor damage. If the motor fails, testing could be delayed, potentially affecting patient results. Read more at govinfonow.com/recall/69671-tosoh-aia-900-analyzer-recall-timing-belt-issue-may-cause.

Source Summary by GovInfoNow · govinfonow.com/recall/69671-tosoh-aia-900-analyzer-recall-timing-belt-issue-may-cause · Updated August 20, 2026 · FDA enforcement record: FDA #Z-0509-2019

Cite this page

“Tosoh AIA-900 Analyzer Recall: Timing Belt Issue May Cause Motor Damage.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69671-tosoh-aia-900-analyzer-recall-timing-belt-issue-may-cause. Based on FDA recall #Z-0509-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0509-2019%22&limit=1).

Tosoh Bioscience Inc recalled the AIA-900 Automated Immunoassay Analyzer due to a potential motor axis damage hazard that may delay patient test results, according to the FDA on 2018-10-05.

How to tell if you have it

Brand: Tosoh Bioscience
Product: AIA-900 Automated Immunoassay Analyzer
Product code: 022930 /022930R
Serial nos.: 10142204 10373208 10493811 10614102 10212711 10403809 10503612 10634103 10253102R 10463110 10513412 10654404

The hazard

If the timing belt tension is not adjusted correctly, lateral load on the motor axis may increase, causing inclination and damage. If the drive motor fails, the analyzer will cease to function, potentially delaying testing and reporting of patient results. Tosoh has received five complaints related to this issue with no serious injuries reported.

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 Tosoh ST AIA-Pack Testosterone Recall (2026-06-12), Tosoh AIA-Pack BHCG Calibrator Recall (2020-08-07), Tosoh AIA-900 Analyzer Recall (2020-05-22), Beckman Coulter AU5800 Chemistry Analyzer Recall (2026-01-30), Olympus HX-400U-30 Ligating Device Recall (2025-10-30), and AVID Medical Halyard Cath Lab Kit Recall (2026-03-13).

How to tell if you have this one

Check for serial numbers: 10142204, 10373208, 10493811, 10614102, 10212711, 10403809, 10503612, 10634103, 10253102R, 10463110, 10513412, 10654404. The AIA-900 analyzer is used for immunoassay testing in medical labs.

Brand
Tosoh Bioscience
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Serial Numbers
Look for the specific serial numbers listed in the recall notice to determine if your analyzer is affected.
Contact Tosoh
Reach out to Tosoh Bioscience for guidance on whether your unit needs adjustment or repair.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 6 states.

FDA distribution: “Worldwide Distribution - US Nationwide in the states of FL, MD, NV, NY, SC, and TX. and Foreign distribution to Cayman Islands, Chile, Columbia, Dominican Republic, Ecuador, Guatemala, Honduras, Peru, Puerto Rico, Uruguay, and Venezuela.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Florida, Maryland, Nevada, New York, Puerto Rico, South Carolina, Texas.

Recall timeline

FDA terminated this recall 23 months after the firm started it.

Oct 5, 2018Firm started the recall
Nov 28, 2018FDA classified it Class II
Dec 5, 2018Published in FDA’s Enforcement Report
Aug 27, 2020FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/69671-tosoh-aia-900-analyzer-recall-timing-belt-issue-may-cause">Tosoh AIA-900 Analyzer Recall: Timing Belt Issue May Cause Motor Damage (GovInfoNow)</a>

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-0509-2019 (October 5, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0509-2019 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.