Aggredyne recalls AggreGuide A-100 instruments with software versions 5.1 or 5.2 that may display 'Low' results due to a software error causing 0 RPM blood mixing. Affected units have serial numbers between xx0001 and xx0160.
The firm identified a software design issue where the improper shut down of the instrument resulted in speeds.csv file contents of the software version 5.1 being erased. Due to this issue, the target RPM for the assay is 0 and the motor output required to achieve this RPM is also 0 . Therefore, when the assay is run, the software applies 0 Volts to the motor and performs a 0 RPM assay. Because of this, there is no mixing of the blood with agonist and no moving of aggregates happens in front of the optical detectors. The resulting PAI is 0 and the result is displayed as Low .
Aggredyne is recalling AggreGuide A-100 blood testing instruments with specific software versions that may show 'Low' results because the software error stops blood mixing. This could lead to inaccurate blood test results.
The software error causes the instrument to run at 0 RPM, which stops blood mixing with the test solution. This results in no movement of blood aggregates in front of the optical detectors, leading to a 'Low' result even when the sample is normal.
Users of the AggreGuide A-100 blood testing instrument with software versions 5.1 or 5.2 and serial numbers between xx0001 and xx0160 are affected. Laboratory staff and medical professionals who use this device for blood tests are most at risk.
Check for the AggreGuide A-100 Instrument with software versions 5.1 or 5.2. Affected units have serial numbers between xx0001 and xx0160.
Verify the software version on your AggreGuide A-100 Instrument. If it is version 5.1 or 5.2, it may be affected.
Check the serial number on your instrument. If it falls between xx0001 and xx0160, it is part of the recall.
The software error causes the instrument to run at 0 RPM, which stops blood mixing and leads to inaccurate 'Low' results.
The recall record does not specify a remedy, so no action is required unless you want to check if your instrument is affected.
Check for software versions 5.1 or 5.2 and serial numbers between xx0001 and xx0160.
We’ve drafted a message you can send Aggredyne to request your refund or repair — edit it as you like.
Subject: Recall Z-1639-2022 — Aggredyne Aggredyne Hello, I own a Aggredyne that is covered by recall Z-1639-2022 from Aggredyne. 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.
