Tosoh recalls AIA-900 analyzers with potential timing belt misalignment causing motor damage. Five complaints reported with no serious injuries. Affected units include specific serial numbers.
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.
Tosoh is recalling AIA-900 Automated Immunoassay Analyzers that may have timing belt tension issues causing motor damage. If the motor fails, testing could be delayed, potentially affecting patient results.
Incorrect timing belt tension can cause the motor axis to become inclined and damaged. This may lead to the analyzer stopping function, causing delays in patient test results. The issue has been observed in five complaints with no serious injuries reported.
Healthcare facilities using the AIA-900 analyzer are most at risk. Patients relying on timely test results could be impacted if the analyzer stops working.
Check for serial numbers: 10142204, 10373208, 10493811, 10614102, 10212711, 10403809, 10503612, 10634103, 10253102R, 10463110, 10513412, 10654404. The AIA-900 analyzer is used for immunoassay testing in medical labs.
Look for the specific serial numbers listed in the recall notice to determine if your analyzer is affected.
Reach out to Tosoh Bioscience for guidance on whether your unit needs adjustment or repair.
No serious injuries have been reported with this issue.
Check if your analyzer has one of the specific serial numbers listed in the recall notice.
Contact Tosoh Bioscience for assistance; they have been inspecting and correcting the issue during preventative maintenance.
We’ve drafted a message you can send Tosoh Bioscience to request your refund or repair — edit it as you like.
Subject: Recall Z-0509-2019 — Tosoh Bioscience Tosoh Bioscience Hello, I own a Tosoh Bioscience that is covered by recall Z-0509-2019 from Tosoh Bioscience. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
