Beckman Coulter recalls FC 500 flow cytometers with potential signal loss causing inaccurate patient results. Affected models include CXP and MXP software versions from 2002-2018.
A manufacturing defect on the amplifier board of the Flow Cytometers my cause signal loss and/or signal drifting resulting in absence of data or a population shift in the data plots. This can impact patient results for any application.
Beckman Coulter is recalling two types of FC 500 flow cytometers that may have signal loss issues, which could lead to inaccurate patient test results. This recall affects laboratory equipment used for medical diagnostics.
A manufacturing defect in the amplifier board can cause signal loss or drifting in the data. This may result in missing patient data or incorrect results in medical tests.
Laboratories using Beckman Coulter FC 500 flow cytometers for medical testing are most at risk. The recall covers specific model numbers and production dates from 2002 to 2018.
Check for model numbers: FC 500 with CXP software (626553) or MXP software (626554). Products were manufactured between January 2002 and January 2018.
Identify if your flow cytometer has model numbers 626553 (CXP software) or 626554 (MXP software).
Ensure your device was manufactured between January 2002 and January 2018.
The recall includes Cytomics FC 500 with CXP software (model 626553) and FC 500 MPL with MXP software (model 626554).
Products were manufactured from January 2002 to January 2018.
The recall states the defect may cause inaccurate patient results but does not mention injury risks.
We’ve drafted a message you can send Beckman Coulter to request your refund or repair — edit it as you like.
Subject: Recall Z-0471-2019 — Beckman Coulter Beckman Coulter Hello, I own a Beckman Coulter that is covered by recall Z-0471-2019 from Beckman Coulter. 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.
