Tosoh recalls AIA-900 and AIA-2000 analyzers due to potential incubator slippage causing mechanical errors and delayed test results. No injuries reported.
Tosoh Bioscience has become aware of a potential issue with the AIA-900 and AIA-2000 analyzers that could result in slippage of the incubator unit contained within the system. If the tension of the timing belt is not adjusted correctly, it is possible for a misalignment that will result in a mechanical error. Tosoh has taken the required actions to inspect the tension of the timing belt during preventative maintenance and correct the instruments where this issue has been observed. If incubator slippage occurs, the unit will cease to function, and a system error will be reported. If this occurs, there may be a delay in testing and reporting patient test results. There have been no reports of injury related to this issue.
Tosoh is recalling AIA-900 and AIA-2000 analyzers because improper timing belt tension can cause incubator slippage, leading to mechanical errors and delayed test results. This issue does not involve injuries or safety hazards for end users.
If the timing belt tension is not adjusted correctly, the incubator unit can slip, causing mechanical errors. This may lead to delayed test results but does not cause injury or damage to the user.
Laboratories using AIA-900 or AIA-2000 analyzers are affected. The risk is low as no injuries have been reported and the issue is corrected during routine maintenance.
Check for product codes 022930 or 022930R on the AIA-900 or AIA-2000 analyzers. These devices are used in laboratories for immunoassay testing.
Tosoh has corrected the issue during preventative maintenance if the timing belt tension is misaligned.
No injuries have been reported related to this issue.
Check for product codes 022930 or 022930R on your AIA-900 or AIA-2000 analyzer.
Tosoh has corrected the issue during preventative maintenance if the timing belt tension is misaligned.
We’ve drafted a message you can send Tosoh Bioscience to request your refund or repair — edit it as you like.
Subject: Recall Z-0600-2019 — Tosoh Bioscience Tosoh Bioscience Hello, I own a Tosoh Bioscience that is covered by recall Z-0600-2019 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.
