The Recall Desk
HighFDA (Devices)·Z-0472-2019·Announced 2018-11-28

Beckman Coulter Flow Cytometers Recalled for Signal Loss Defect

Beckman Coulter is recalling 2,549 flow cytometers worldwide due to a manufacturing defect that may cause signal loss or drifting, potentially affecting patient results.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device defect that can impact patient results, representing a risk-of-harm product where specific injury or illness has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

Beckman Coulter Inc. is recalling 2,549 units of COULTER EPICS XL, COULTER EPICS XL-MCL, and SYSTEM II Software flow cytometers. The recall covers units distributed worldwide, including the United States and Puerto Rico, as well as numerous countries across Asia, Europe, Africa, and the Americas.

The recall is due to a manufacturing defect on the amplifier board that may cause signal loss and/or signal drifting. This defect can result in the absence of data or a population shift in data plots, which can impact patient results for any application.

The affected products were manufactured between specific dates: FC-500 units from January 22, 2002, to January 31, 2018, and EPICS XL/XL-MCL units from November 1, 1992, to March 15, 2013. Users should contact Beckman Coulter for further instructions on how to address this defect.

The recalled product

Product
COULTER EPICS XL Flow Cytometer COULTER EPICS XL-MCL Flow Cytometer SYSTEM II Software
Manufacturer
Beckman Coulter Inc.
Category
Medical Device — Laboratory Equipment
Hazard
Affected units
2,549

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • XL Flow Cytometer 100-240V
  • XL/MCL Flow Cytometer 100-240V
  • MCL

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 2 recalled by Beckman Coulter Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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