Tosoh recalls AIA-2000 and AIA-900 analyzers with potential incubator slippage causing testing delays. No injuries reported. Check product codes 022100, 022100R, 022101, 022101R.
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-2000 and AIA-900 analyzers due to a potential incubator slippage issue that could cause mechanical errors and delays in patient test results. This does not involve injury reports, so the risk is low for most users.
If the timing belt tension is incorrect, the incubator unit can slip, causing mechanical errors. This stops the analyzer from functioning and reports system errors, delaying patient test results. No injuries have been reported.
Healthcare facilities using the AIA-2000 or AIA-900 analyzers are most affected. Patients receiving tests with these devices may experience delays in results.
Check for product codes 022100, 022100R, 022101, or 022101R on the device. The AIA-2000 and AIA-900 analyzers are the affected models.
Look for product codes 022100, 022100R, 022101, or 022101R on the device label.
No injuries have been reported related to this issue.
Check the product codes on the device. If affected, contact Tosoh Bioscience for guidance.
Yes, if incubator slippage happens, the analyzer will stop functioning and report a system error.
We’ve drafted a message you can send Tosoh Bioscience to request your refund or repair — edit it as you like.
Subject: Recall Z-0599-2019 — Tosoh Bioscience Tosoh Bioscience Hello, I own a Tosoh Bioscience that is covered by recall Z-0599-2019 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.
