Tosoh Bioscience has become aware of a potential issue with the AIA-900 and AIA-2000 analyzers that could result in slippage of the incubator unit contained within the system. If the tension of the timing belt is not adjusted correctly, it is possible for a misalignment that will result in a mechanical error. Tosoh has taken the required actions to inspect the tension of the timing belt during preventative maintenance and correct the instruments where this issue has been observed. If incubator slippage occurs, the unit will cease to function, and a system error will be reported. If this occurs, there may be a delay in testing and reporting patient test results. There have been no reports of injury related to this issue.
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Contact the company
📍Recalling firmTosoh Bioscience Inc3600 Gantz Rd · Grove City, OH 43123-1895
✎ GovInfoNow plain-language explainer
Tosoh is recalling AIA-2000 and AIA-900 analyzers due to a potential incubator slippage issue that could cause mechanical errors and delays in patient test results. This does not involve injury reports, so the risk is low for most users. Read more at govinfonow.com/recall/69721-tosoh-aia-2000-analyzer-recall-incubator-slippage-risk.
“Tosoh AIA-2000 Analyzer Recall: Incubator Slippage Risk.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69721-tosoh-aia-2000-analyzer-recall-incubator-slippage-risk. Based on FDA recall #Z-0599-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0599-2019%22&limit=1).
The FDA announced on Sept. 28, 2018, that Tosoh Bioscience Inc is recalling AIA-2000 and AIA-900 analyzers due to potential incubator slippage from incorrect timing belt tension. The agency issued recall number Z-0599-2019 for the voluntary Class II action.
How to tell if you have it
AIA-2000 Analyzer, Product code 022100
AIA-2000 Analyzer, Product code 022100R
AIA-2000 Analyzer, Product code 022101
AIA-2000 Analyzer, Product code 022101R
The hazard
GovInfoNow's records show the potential issue involves slippage of the incubator unit if timing belt tension is not adjusted correctly, which may cause mechanical error and system failure. If this occurs, there may be a delay in testing and reporting patient test results. There have been no reports of injury related to this issue.
Context
GovInfoNow's records show Tosoh Bioscience Inc has had 19 other recalls on record since June 11, 2017. Other recent recalls include the Tosoh ST AIA-Pack Testosterone Recall (June 12, 2026), the Tosoh AIA-Pack BHCG Calibrator Recall (Aug. 7, 2020), and the Tosoh AIA-900 Analyzer Recall (May 22, 2020). Other recent recalls of similar products include the Beckman Coulter AU5800 Chemistry Analyzer Recall (Jan. 30, 2026), the AVID Medical Halyard Cath Lab Kit Recall (March 13, 2026), and the Boston Scientific Intracept Access Instruments Recall (April 22, 2026).
How to tell if you have this one
Check for product codes 022100, 022100R, 022101, or 022101R on the device. The AIA-2000 and AIA-900 analyzers are the affected models.
Brand
Tosoh Bioscience
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Terminated
Distribution
US Nationwide distribution and International distribution to Colombia, Chile, Honduras, Cayman Islands, Panama, Costa Rica, Guatemala, Venezuela, Uruguay, Peru, and Ecuador.
Recall number
Product, codes & lots
Quantity
Z-0599-2019
AIA-2000 Analyzer, Product code 022100, 022100R, 022101, 022101R The AIA-2000 analyzer and AIA-900 analyzer are capable of performing three methods of immunoassay: an immunoenzymetric (IEMA) or sandwich immunoassay, a competitive binding (EIA) immunoassay, and a two-step immunoenzymetric immunoassay.; Affects all active analyzers. 022100, 022100R, 022101, 022101R
95
Z-0600-2019
AIA-900Analyzer, Product code 022930, 022930R The AIA-2000 analyzer and AIA-900 analyzer are capable of performing three methods of immunoassay: an immunoenzymetric (IEMA) or sandwich immunoassay, a competitive binding (EIA) immunoassay, and a two-step immunoenzymetric immunoassay.; Affects all active analyzers. 022930, 022930R
395
Based on the official FDA remedy
What to do — step by step
Check Product Codes
Look for product codes 022100, 022100R, 022101, or 022101R on the device label.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “US Nationwide distribution and International distribution to Colombia, Chile, Honduras, Cayman Islands, Panama, Costa Rica, Guatemala, Venezuela, Uruguay, Peru, and Ecuador.” 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 23 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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-0599-2019 (September 28, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0599-2019 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.