Tosoh AIA-900 Sorters Recalled for Potential Photo Interrupter Malfunction
Tosoh Bioscience Inc is recalling AIA-900 9tray and 19tray Sorters due to a potential malfunction of the photo interrupter caused by aging.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The source text describes a potential malfunction due to aging without reporting any injuries, illnesses, or specific adverse health consequences, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Tosoh Bioscience Inc is recalling the Tosoh Sorter 9tray (Product Code 022931) and Tosoh Sorter 19tray (Product Code 022932). These devices are used to support the automation of AIA-900 systems. The recall covers 565 total devices distributed in the United States and Latin America.
The recall was initiated due to a potential malfunction of the photo interrupter (PI). This potential malfunction has been attributed to aging and premature deterioration of the PI collector current. The affected units include the AIA-900 19tray Sorter with serial numbers 10000109 to 80136909 and the AIA-900 9tray Sorter with serial numbers 10000109 to 10707402.
No specific instructions for consumers are provided in the source text. Users of these devices should verify their serial numbers against the affected ranges listed above.
The recalled product
- Product
- 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.
- Manufacturer
- Tosoh Bioscience Inc
- Hazard
- Affected units
- 565
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Tosoh Bioscience Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Tosoh Bioscience Inc
See all →- ModerateTosoh ST AIA-Pack Testosterone Diagnostic Test Kit Recall
FDA (Devices) · 2026-07-22
- ModerateTosoh Thyroglobulin Antibody Calibrator Recalled for Calibration Failures
FDA (Devices) · 2021-03-17
- ModerateTosoh Bioscience Recalls AIA-PACK HCG Calibrator Sets Due to Stability Issues
FDA (Devices) · 2020-09-23
- ModerateTosoh Bioscience Recalls AIA-PACK BHCG Calibration Sets Due to Stability Issues
FDA (Devices) · 2020-09-23
- HighTosoh AIA-900 Analyzer Recalled for Substrate Monitoring Defect
FDA (Devices) · 2020-07-01
Same hazard · malfunction
See all →- ModerateCriticare nGenuity Patient Monitor Recalled for Capnography Setup Error
FDA (Devices) · 2026-09-30
- HighFresenius BlueStar Hemodialysis Machines Recalled for Alarm Defects
FDA (Devices) · 2026-09-02
- ModerateOlympus 4K UHD LCD Monitors Recalled Due to Potential Connector Faults
FDA (Devices) · 2026-07-29
- High
- ModeratePhilips Azurion 3M15 Medical Imaging Systems Recalled Due to Software Issue
FDA (Devices) · 2026-06-10
Similar recalls
- HighTosoh AIA-900 Analyzer Recalled Due to Pickup Arm Malfunction
FDA (Devices) · 2018-11-21
- HighTosoh AIA-900 Analyzer Recalled for Substrate Monitoring Defect
FDA (Devices) · 2020-07-01
- ModerateTosoh AIA-900 Analyzer Software Issue May Delay Patient Testing
FDA (Devices) · 2018-11-28
- ModerateTosoh AIA-900 and AIA-2000 Analyzers Recalled for Incubator Slippage Risk
FDA (Devices) · 2018-12-19
- ModerateTosoh AIA-900 Analyzer Recalled for Potential Drive Motor Failure
FDA (Devices) · 2018-12-05
- ModerateTosoh AIA-2000 and AIA-900 Analyzers Recalled for Incubator Slippage
FDA (Devices) · 2018-12-19