Beckman Coulter recalls EPICS XL Flow Cytometers with software defect causing signal loss that may impact patient results. Affected units include specific models and serial ranges from 2002-2013.
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 EPICS XL Flow Cytometers due to a software defect that can cause signal loss or data shifts, potentially affecting patient results. This recall affects specific models and serial numbers manufactured between 2002 and 2013.
The amplifier board defect can cause signal loss or drifting in data, leading to missing results or shifted populations in test outputs. This may affect the accuracy of patient results for various medical applications.
Healthcare facilities using EPICS XL Flow Cytometers for medical testing are most likely affected. Patients receiving tests on these devices may be impacted if the software defect causes inaccurate results.
Check for model numbers like EPICS XL, EPICS XL-MCL, or system II software with catalog numbers from the list provided. Affected units were manufactured from January 2002 to March 2013.
Identify if your device is an EPICS XL or EPICS XL-MCL Flow Cytometer with the specific catalog numbers listed in the recall notice.
Confirm your device was manufactured between January 2002 and March 2013 based on the serial numbers provided in the recall.
EPICS XL and EPICS XL-MCL Flow Cytometers with specific catalog numbers from the list provided in the recall notice, manufactured between January 2002 and March 2013.
The defect can cause signal loss or drifting in data, potentially leading to missing results or shifted populations in test outputs, which may impact patient results.
No action is needed if your device was manufactured outside the affected date range of January 2002 to March 2013.
We’ve drafted a message you can send Beckman Coulter to request your refund or repair — edit it as you like.
Subject: Recall Z-0472-2019 — Beckman Coulter Beckman Coulter Hello, I own a Beckman Coulter that is covered by recall Z-0472-2019 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.
