Lower risk Medical device recall · FDA · Published August 23, 2018

Tosoh AIA-360 Analyzer Recall: Labeling Changes Risk System Failure

Tosoh recalls AIA-360 analyzers due to labeling changes affecting maintenance procedures. Failure to follow new requirements may cause corrosion, contamination, or system failure. Affected units have product code 019945/019945R.

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

🇺🇸 FDA recall #Z-0559-2019Medical device Tosoh ›

Lower-risk recall

The firm has implemented new product labeling changes for the Tosoh AIA-360 Analyzer. These labeling changes affect the Tosoh Quick Reference Guide, Training Manual and Training DVD previously provided by Tosoh Bioscience. These changes are being made to align the Tosoh Quick Reference Guide and associated training materials to the Operators Manual and provide clarification to the requirement that the maintenance of the B/F probe is to be performed by Tosoh a field service representative, the requirement for use of 70% Ethanol during daily shutdown procedures and the requirement for use of CAP Class 1 reagent grade water for dilution of the concentrated wash and diluent solutions and reconstitution of lyophilized reagents. Failure to follow these requirements may negatively affect system performance, lead to corrosion of instrument components over time, or result in bacterial contamination, respectively.

Take action

Contact the company

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

✎ GovInfoNow plain-language explainer

Tosoh is recalling its AIA-360 Automated Immunoassay Analyzer (product codes 019945/019945R) because updated labeling changes affect maintenance procedures. If users don't follow the new requirements for probe maintenance, ethanol use, and water quality, the device could corrode, become contaminated, or malfunction. Read more at govinfonow.com/recall/69977-tosoh-aia-360-analyzer-recall-labeling-changes-risk-system-failure.

Source Summary by GovInfoNow · govinfonow.com/recall/69977-tosoh-aia-360-analyzer-recall-labeling-changes-risk-system-failure · Updated August 20, 2026 · FDA enforcement record: FDA #Z-0559-2019

Cite this page

“Tosoh AIA-360 Analyzer Recall: Labeling Changes Risk System Failure.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69977-tosoh-aia-360-analyzer-recall-labeling-changes-risk-system-failure. Based on FDA recall #Z-0559-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0559-2019%22&limit=1).

The FDA announced on 2018-08-23 that Tosoh Bioscience Inc is recalling the AIA-360 Analyzer, product code 019945/019945R. The firm implemented labeling changes to align training materials with the Operators Manual. These updates clarify maintenance and reagent requirements for the in vitro diagnostic device.

How to tell if you have it

Brand: Tosoh
Product: AIA-360 Analyzer
Product code: 019945/019945R

The hazard

Failure to follow the clarified requirements may negatively affect system performance, lead to corrosion of instrument components over time, or result in bacterial contamination. The recall addresses changes to the Tosoh Quick Reference Guide, Training Manual and Training DVD.

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), Omnicell i.v.Station Label Stock Recall (2026-03-25) and FreeStyle Libre 14 Day Sensor Recall (2025-11-24).

How to tell if you have this one

Check for the product code 019945 or 019945R on the device. The recall affects all units sold with these codes, as the labeling changes apply to all devices.

Brand
Tosoh
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Review Updated Labeling
Check the device for new labeling changes that specify maintenance requirements for probes, ethanol use, and water quality.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “Worldwide Distribution: US (Nationwide) and countries of: Mexico, Canada, Colombia, Chile, Venezuela, Ecuador, Uruguay, Peru, and Honduras.” 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 2.2 years after the firm started it.

Aug 23, 2018Firm started the recall
Dec 6, 2018FDA classified it Class II
Dec 12, 2018Published in FDA’s Enforcement Report
Oct 20, 2020FDA terminated the recall

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

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Do I need to return the device?

The recall does not require returning the device; users must follow the updated labeling instructions to maintain proper function.

Similar recalls

Latest medical device recalls

Keep exploring

More Tosoh recalls

Link to this recall

<a href="https://govinfonow.com/recall/69977-tosoh-aia-360-analyzer-recall-labeling-changes-risk-system-failure">Tosoh AIA-360 Analyzer Recall: Labeling Changes Risk System Failure (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-0559-2019 (August 23, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0559-2019 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.