Tosoh¿Sorter 9tray, Product Code 022931and Tosoh¿Sorter 19tray, Product Code 022932. Product U...
FDA Device Recall #Z-0492-2018 — Class II — June 11, 2017
Recall Summary
| Recall Number | Z-0492-2018 |
| Classification | Class II — Moderate risk |
| Date Initiated | June 11, 2017 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Tosoh Bioscience Inc |
| Location | Grove City, OH |
| Product Type | Devices |
| Quantity | 565 total devices U.S. |
Product Description
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.
Reason for 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.
Distribution Pattern
Worldwide Distribution - U.S. Nationwide - Latin America
Lot / Code Information
AIA-900 19tray Sorter with S/N 10000109 to S/N 80136909. AIA-900 9tray Sorter with S/N 10000109 to S/N 10707402.
Other Recalls from Tosoh Bioscience Inc
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2968-2020 | Class II | Tosoh Bioscience AIA-PACK BHCG Calibration Veri... | Aug 7, 2020 |
| Z-2967-2020 | Class II | Tosoh Bioscience AIA- PACK HCG Calibrator Set-I... | Aug 7, 2020 |
| Z-2423-2020 | Class II | AIA-900 Analyzer, Part no. 022930, UDI 04560189... | May 22, 2020 |
| Z-1420-2020 | Class II | AIA-360 Automated Immunoassay Analyzer, Product... | Jan 10, 2020 |
| Z-0675-2019 | Class II | ST AIA-PACK Homocysteine (HCY) is designed for ... | Nov 30, 2018 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.