Lower risk Medical device recall · FDA · Published May 22, 2020

Tosoh AIA-900 Analyzer Recall: Substrate Monitoring System May Cause Wrong Test Results

Tosoh Bioscience recalls AIA-900 Analyzers with serial numbers 10030810 and higher due to a substrate monitoring system that may not detect empty bottles, leading to incorrect test results.

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

🇺🇸 FDA recall #Z-2423-2020Medical device Tosoh Bioscience ›

Lower-risk recall

The Substrate Monitoring System in the AIA-900 Analyzer did not detect an empty substrate bottle. The issue may lead to erroneous immunoassay test results.

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Contact the company

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

✎ GovInfoNow plain-language explainer

Tosoh Bioscience is recalling AIA-900 Analyzers with serial numbers starting from 10030810 because the substrate monitoring system might not detect when a test bottle is empty. This could cause inaccurate immunoassay test results, which is important for medical testing accuracy. Read more at govinfonow.com/recall/65099-tosoh-aia-900-analyzer-recall-substrate-monitoring-system-may-cause.

Source Summary by GovInfoNow · govinfonow.com/recall/65099-tosoh-aia-900-analyzer-recall-substrate-monitoring-system-may-cause · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2423-2020

Cite this page

“Tosoh AIA-900 Analyzer Recall: Substrate Monitoring System May Cause Wrong Test Results.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/65099-tosoh-aia-900-analyzer-recall-substrate-monitoring-system-may-cause. Based on FDA recall #Z-2423-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2423-2020%22&limit=1).

The FDA announced on May 22, 2020, that Tosoh Bioscience Inc is recalling the AIA-900 Analyzer due to a hazard that may lead to erroneous immunoassay test results. The agency issued recall number Z-2423-2020 for the device.

How to tell if you have it

Brand: Tosoh Bioscience
Product: AIA-900 Analyzer
Part no.: 022930
UDI: 04560189283992
Serial numbers: 10030810; 10101008; 10142204; 10212411; 10253902; 10263902 and higher serial numbers (Distributed in US); 10081002, 10273603, 10303804R, 10343407R, 10413909R, 10423809R, 10483211, 10564601, 10564701, 10564901, 10594002, 10594802, 10614402R, 10634303R, 10634603, 10664304, 10674505, 10674605, 10694506, 10734208R, 10734308, 10744309, 10744409, 10744609, 10855903, 10865003, 11006601, 11026101, 11026201, 11026301, 11026702, 11026802, 11026902, 11046205R, 11076209R, 11086710, 11106112, 11106212, 11106312, 11106412, 11106512, 11187906, 11197006, 11197106, 11197206, 11197306, 11247509, 11247809, 11267610, 11297812, 11368506, 11368606, 11368706, 11368806, 11368906, 11378006, 11398708, 11398808, 11398908, 11408008, 11438711, 11438811, 11438911, 11448011, 11448112, 11448212, 11479102, 11479202, 11479302 (Distributed Internationally)

The hazard

According to the FDA, the Substrate Monitoring System in the AIA-900 Analyzer did not detect an empty substrate bottle. The issue may lead to erroneous immunoassay test 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 Tosoh ST AIA-Pack Testosterone Recall (2026-06-12), Tosoh AIA-Pack BHCG Calibrator Recall (2020-08-07), and Tosoh AIA-360 Analyzer Software Issue Recall (2020-01-10). Other recent recalls of similar products include Roche Elecsys Anti-TSHR Assay Recall (2025-11-21), Siemens Atellica CH Urine Albumin Recall (2026-07-06), and Beckman Coulter AU5800 Chemistry Analyzer Recall (2026-01-30).

How to tell if you have this one

Check the serial number on your AIA-900 Analyzer. The recall includes units with serial numbers starting from 10030810 and higher, both in the US and internationally.

Brand
Tosoh Bioscience
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Serial Number
Look for the serial number on your AIA-900 Analyzer to see if it starts with 10030810 or higher.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “Domestic distribution nationwide. Foreign distribution to Chile, Costa Rica, Cayman Islands, Dominican Republic, Ecuador, Guatemala, Honduras, Peru, Republic of Panama, El Salvador, and Uruguay.” 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 4.3 years after the firm started it.

May 22, 2020Firm started the recall
Jun 23, 2020FDA classified it Class II
Jul 1, 2020Published in FDA’s Enforcement Report
Aug 29, 2024FDA terminated the recall

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

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Keep exploring

More Tosoh Bioscience recalls

Link to this recall

<a href="https://govinfonow.com/recall/65099-tosoh-aia-900-analyzer-recall-substrate-monitoring-system-may-cause">Tosoh AIA-900 Analyzer Recall: Substrate Monitoring System May Cause Wrong Test Results (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-2423-2020 (May 22, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2423-2020 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.