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AIA-900 Automated Immunoassay Analyzer, product code 022930 /022930R Product Usage: The AIA-9...

FDA Device Recall #Z-0509-2019 — Class II — October 5, 2018

Recall Summary

Recall Number Z-0509-2019
Classification Class II — Moderate risk
Date Initiated October 5, 2018
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Tosoh Bioscience Inc
Location Grove City, OH
Product Type Devices
Quantity 247

Product Description

AIA-900 Automated Immunoassay Analyzer, product code 022930 /022930R Product Usage: The AIA-900 is capable of performing three methods of immunoassay: an immunoenzymetric (IEMA) or sandwich immunoassay, a competitive binding (EIA) immunoassay, and a two-step immunoenzymetric immunoassay. An antigen-antibody reaction begins by combining a patient sample, control, or calibrator with a diluent in an immunoreaction test cup from the AIA-PACK reagent series.

Reason for Recall

Tosoh Bioscience has become aware of a potential issue with the axis base of the turntable rotation drive motor on the AIA-900 Analyzer. If the tension of the timing belt between the turntable rotation pulley and drive motor is not adjusted correctly, it is possible to increase the lateral load on the motor axis resulting in the inclination and damage of the motor axis. Since January 12, 2017, Tosoh has been inspecting the tension of the timing belt during scheduled preventative maintenance visit and correcting the analyzers where this issue has been observed. If the drive motor fails, the AIA-900 analyzer will cease to function and will be unavailable for use. If this issue occurs, there may be a delay in testing and reporting patient test results. Tosoh has received five (5) complaints related to this issue with no serious injuries reported.

Distribution Pattern

Worldwide Distribution - US Nationwide in the states of FL, MD, NV, NY, SC, and TX. and Foreign distribution to Cayman Islands, Chile, Columbia, Dominican Republic, Ecuador, Guatemala, Honduras, Peru, Puerto Rico, Uruguay, and Venezuela.

Lot / Code Information

Serial nos. 10142204 10373208 10493811 10614102 10212711 10403809 10503612 10634103 10253102R 10463110 10513412 10654404

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.

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