Tosoh Bioscience recalls AIA-900 Analyzers with serial numbers 10030810 and higher due to a substrate monitoring system that may not detect empty bottles, leading to incorrect test results.
The Substrate Monitoring System in the AIA-900 Analyzer did not detect an empty substrate bottle. The issue may lead to erroneous immunoassay test results.
Tosoh Bioscience is recalling AIA-900 Analyzers with serial numbers starting from 10030810 because the substrate monitoring system might not detect when a test bottle is empty. This could cause inaccurate immunoassay test results, which is important for medical testing accuracy.
The substrate monitoring system in the AIA-900 Analyzer may fail to detect an empty substrate bottle. This can lead to incorrect test results because the analyzer continues running without knowing the bottle is empty.
Users of the AIA-900 Analyzer for medical testing are affected. Those who have the device with serial numbers 10030810 or higher are most at risk.
Check the serial number on your AIA-900 Analyzer. The recall includes units with serial numbers starting from 10030810 and higher, both in the US and internationally.
Look for the serial number on your AIA-900 Analyzer to see if it starts with 10030810 or higher.
Tosoh Bioscience is recalling AIA-900 Analyzers with serial numbers starting from 10030810 because the substrate monitoring system may not detect an empty substrate bottle, leading to incorrect test results.
Check the serial number on your device. If it starts with 10030810 or higher, it is affected.
The recall does not specify a remedy, so you should check with Tosoh Bioscience for further instructions.
We’ve drafted a message you can send Tosoh Bioscience to request your refund or repair — edit it as you like.
Subject: Recall Z-2423-2020 — Tosoh Bioscience Tosoh Bioscience Hello, I own a Tosoh Bioscience that is covered by recall Z-2423-2020 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.
