Lower risk Medical device recall · FDA · Published September 28, 2018

Tosoh AIA-2000 Analyzer Recall: Incomplete Washing May Cause False Test Results

Tosoh Bioscience recalls AIA-2000LA and AIA-2000ST analyzers with serial numbers 10038409, 10038509, 10048009R, 10058011, 10069507, 80018112, 80039511. Incomplete washing may cause false test results for some blood tests.

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

🇺🇸 FDA recall #Z-0475-2019Medical device Tosoh Bioscience ›

Lower-risk recall

There is a possibility that the liquid suction pump on some AIA-2000 analyzers may not perform as intended and cause an insufficient volume of wash solution to be removed during the washing step. Incomplete washing of the sample may result in falsely elevated test results for the sandwich assays and falsely decreased test results for the competitive binding assays. Insufficient washing is detectable through review of the calibration data and QC trending. For example, if incomplete washing occurs, the reported values for the zero- calibration rate will be above the acceptance range. The calibration value may shift and the instrument will not calibrate successfully. If this issue occurs, there may be a delay in testing and reporting patient test results. There have been no user or patient injuries reported related to this issue.

Take action

Contact the company

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

✎ GovInfoNow plain-language explainer

Tosoh Bioscience is recalling AIA-2000LA and AIA-2000ST analyzers that may not wash samples properly, leading to false test results. This could delay patient test results and cause inaccurate blood test results for some tests. Read more at govinfonow.com/recall/69723-tosoh-aia-2000-analyzer-recall-incomplete-washing-may-cause-false.

Source Summary by GovInfoNow · govinfonow.com/recall/69723-tosoh-aia-2000-analyzer-recall-incomplete-washing-may-cause-false · Updated August 20, 2026 · FDA enforcement record: FDA #Z-0475-2019

Cite this page

“Tosoh AIA-2000 Analyzer Recall: Incomplete Washing May Cause False Test Results.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69723-tosoh-aia-2000-analyzer-recall-incomplete-washing-may-cause-false. Based on FDA recall #Z-0475-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0475-2019%22&limit=1).

Tosoh Bioscience Inc recalled AIA-2000 Analyzers (Model Nos. AIA-2000LA, AIA-2000ST) due to a potential liquid suction pump failure causing insufficient wash solution removal, according to the FDA on 2018-09-28.

How to tell if you have it

Brand: Tosoh Bioscience
Product: AIA-2000 Analyzer
Model Nos.: AIA-2000LA, AIA-2000ST
Serial Nos.: 10038409, 10038509, 10048009R, 10058011, 10069507, 80018112, 80039511
Quantity: 7 units
Distribution: US Nationwide; Florida, Kentucky, Maryland, Ohio, Pennsylvania, Texas

The hazard

The liquid suction pump may not perform as intended, causing an insufficient volume of wash solution to be removed during the washing step. This incomplete washing may result in falsely elevated test results for sandwich assays and falsely decreased results for competitive binding assays. There have been no user or patient injuries reported related to this issue.

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-900 Analyzer Recall (2020-05-22). Other recent recalls of similar products include Siemens Atellica CH Urine Albumin Recall (2026-07-06) and Vivoo Test Strips Recall (2025-11-22).

How to tell if you have this one

Check if your analyzer has serial numbers 10038409, 10038509, 10048009R, 10058011, 10069507, 80018112, or 80039511. The AIA-2000LA and AIA-2000ST models are affected.

Brand
Tosoh Bioscience
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Serial Numbers
Identify if your analyzer has the listed serial numbers: 10038409, 10038509, 10048009R, 10058011, 10069507, 80018112, or 80039511.
Review Calibration Data
Check calibration data for values above the acceptance range, which may indicate incomplete washing.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 6 states.

FDA distribution: “US Nationwide distribution in the states of Florida, Kentucky, Maryland, Ohio, Pennsylvania, and Texas.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Florida, Kentucky, Maryland, Ohio, Pennsylvania, Texas.

Recall timeline

FDA terminated this recall 20 months after the firm started it.

Sep 28, 2018Firm started the recall
Nov 16, 2018FDA classified it Class II
Nov 28, 2018Published in FDA’s Enforcement Report
May 29, 2020FDA terminated the recall

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

Similar recalls

Latest medical device recalls

Keep exploring

More Tosoh Bioscience recalls

Link to this recall

<a href="https://govinfonow.com/recall/69723-tosoh-aia-2000-analyzer-recall-incomplete-washing-may-cause-false">Tosoh AIA-2000 Analyzer Recall: Incomplete Washing May Cause False 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-0475-2019 (September 28, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0475-2019 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.