Tosoh Bioscience has become aware of a potential issue with the pickup arm and pickup arm motor on the AIA-900 Analyzer. If the pickup arm or pickup arm motor malfunctions, the analyzer will cease to function and result in an inability to test patient samples. This may cause a delay in testing and reporting patient results. Tosoh has received fifty-one (51) complaints related to this issue with no serious injuries reported.
Take action
Contact the company
📍Recalling firmTosoh Bioscience Inc3600 Gantz Rd · Grove City, OH 43123-1895
“Tosoh AIA-900 Analyzer Recall: Pickup Arm Malfunction Causes Testing Delays.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69670-tosoh-aia-900-analyzer-recall-pickup-arm-malfunction-causes-testing. Based on FDA recall #Z-0469-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0469-2019%22&limit=1).
The FDA announced on 2018-10-05 that Tosoh Bioscience Inc is recalling the AIA-900 Analyzer due to a potential pickup arm malfunction that may prevent patient sample testing. The agency classified the recall as Class II.
How to tell if you have it
Brand: Tosoh
Product: AIA-900 Analyzer
Product codes: 022930, 022930R
Units affected: 393
The hazard
According to the FDA, a malfunction of the pickup arm or motor may cause the analyzer to cease functioning, resulting in an inability to test patient samples and delaying reporting. Tosoh has received fifty-one (51) complaints related to this issue with no serious injuries reported.
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 Beckman Coulter AU5800 Chemistry Analyzer Recall (2026-01-30), Beckman Coulter DxC 700 AU Recall (2026-01-30), and AU480 Chemistry Analyzer May Show Error Message Causing Delay in Patient Results (2026-08-03).
How to tell if you have this one
Check for product codes 022930 or 022930R on the AIA-900 Analyzer. All units are affected, so no specific purchase date or location is needed.
Brand
Tosoh
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check for Product Code
Look for product codes 022930 or 022930R on the analyzer.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Distributed nationwide. Foreign distribution to Canada and 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 2.1 years 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-0469-2019 (October 5, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0469-2019 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.