Tosoh AIA-900 Analyzer Recall: Photo Interrupter Malfunction Risk
Tosoh recalls AIA-900 analyzers with serial numbers 10000103 to 11147003 due to potential photo interrupter failure from aging. Affected users should contact Tosoh for details.
Lower-risk recall
This recall has been initiated due to a potential malfunction of the photo interrupter (Pl). The potential malfunction has been attributed to aging and premature deterioration of the Pl collector current.
Contact the company
What happened, in plain English
Tosoh is recalling AIA-900 automated enzyme immunoassay analyzers with specific serial numbers because the photo interrupter component may fail due to aging. This could lead to inaccurate test results or system malfunctions if the device is used without proper maintenance. Read more at govinfonow.com/recall/73885-tosoh-aia-900-analyzer-recall-photo-interrupter-malfunction-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/73885-tosoh-aia-900-analyzer-recall-photo-interrupter-malfunction-risk · Updated September 23, 2026 · FDA enforcement record: FDA #Z-0491-2018
Cite this page
“Tosoh AIA-900 Analyzer Recall: Photo Interrupter Malfunction Risk.” GovInfoNow, updated September 23, 2026. https://govinfonow.com/recall/73885-tosoh-aia-900-analyzer-recall-photo-interrupter-malfunction-risk. Based on FDA recall #Z-0491-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0491-2018%22&limit=1).
Why it’s dangerous
The photo interrupter sensor in the AIA-900 may deteriorate over time, causing the device to malfunction. This could result in inaccurate test results or system errors during diagnostic testing. However, the recall does not indicate immediate safety hazards like injury or fire.
Who’s affected
Users of the AIA-900 analyzer with serial numbers 10000103 to 11147003 are affected. Laboratory staff and healthcare professionals using this device for diagnostic testing are most at risk.
How to tell if you have this one
Check the serial number on your AIA-900 analyzer. The affected units have serial numbers from 10000103 to 11147003. The device is used for in vitro diagnostic testing of blood samples.
- Brand
Tosoh- Category
Medical device
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
Worldwide Distribution - U.S. Nationwide - Latin America
| Recall number | Product, codes & lots |
|---|---|
| Z-0491-2018 | Tosoh¿Automated Enzyme Immunoassay Analyzer AIA-900, Product Catalog No. 022930. Product Usage: The AIA-900 Automated Enzyme Immunoassay System is an automated analyzer for in vitro diagnostic use that measures a variety of substances in serum, plasma, and or urine using the AIA-PACK reagent series.; All Photo Interrupter sensors that are current in AIA-900 analyzers with serial number(S/N) 10000103 to S/N 11147003. |
| Z-0492-2018 | Tosoh¿Sorter 9tray, Product Code 022931and Tosoh¿Sorter 19tray, Product Code 022932. Product Usage: The AIA-900 9tray Sorter and AIA-900 19tray Sorter supports the automation of the AIA-900 systems.; AIA-900 19tray Sorter with S/N 10000109 to S/N 80136909. AIA-900 9tray Sorter with S/N 10000109 to S/N 10707402. |
What to do — step by step
Check Serial Number
Identify the serial number on your AIA-900 analyzer to determine if it falls within the range 10000103 to 11147003.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Worldwide Distribution - U.S. Nationwide - Latin America” 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 2.6 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
What should I do if my device is affected?
Contact Tosoh directly to confirm if your device is affected and follow their instructions for next steps.
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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-0491-2018 (June 11, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0491-2018 to see it in context.
- Plain-language summary written by qwen3:4b on September 23, 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.