Tosoh Bioscience recalls AIA-2000LA and AIA-2000ST analyzers with serial numbers 10038409, 10038509, 10048009R, 10058011, 10069507, 80018112, 80039511. Incomplete washing may cause false test results for some blood tests.
There is a possibility that the liquid suction pump on some AIA-2000 analyzers may not perform as intended and cause an insufficient volume of wash solution to be removed during the washing step. Incomplete washing of the sample may result in falsely elevated test results for the sandwich assays and falsely decreased test results for the competitive binding assays. Insufficient washing is detectable through review of the calibration data and QC trending. For example, if incomplete washing occurs, the reported values for the zero- calibration rate will be above the acceptance range. The calibration value may shift and the instrument will not calibrate successfully. If this issue occurs, there may be a delay in testing and reporting patient test results. There have been no user or patient injuries reported related to this issue.
Tosoh Bioscience is recalling AIA-2000LA and AIA-2000ST analyzers that may not wash samples properly, leading to false test results. This could delay patient test results and cause inaccurate blood test results for some tests.
The liquid suction pump in some analyzers may not remove enough wash solution during testing. This can cause false high results for some blood tests and false low results for others. The issue is detectable through calibration data but may delay test results.
Healthcare facilities using the AIA-2000 analyzers with the listed serial numbers are most at risk. Patients receiving tests on these analyzers may get inaccurate results.
Check if your analyzer has serial numbers 10038409, 10038509, 10048009R, 10058011, 10069507, 80018112, or 80039511. The AIA-2000LA and AIA-2000ST models are affected.
Identify if your analyzer has the listed serial numbers: 10038409, 10038509, 10048009R, 10058011, 10069507, 80018112, or 80039511.
Check calibration data for values above the acceptance range, which may indicate incomplete washing.
No user or patient injuries have been reported related to this issue.
If your analyzer has the listed serial numbers (10038409, 10038509, 10048009R, 10058011, 10069507, 80018112, or 80039511), it may have incomplete washing issues.
Incomplete washing may cause false high results for some blood tests and false low results for others, but the issue is detectable through calibration data.
We’ve drafted a message you can send Tosoh Bioscience to request your refund or repair — edit it as you like.
Subject: Recall Z-0475-2019 — Tosoh Bioscience Tosoh Bioscience Hello, I own a Tosoh Bioscience that is covered by recall Z-0475-2019 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.
