COULTER EPICS XL Flow Cytometer COULTER EPICS XL-MCL Flow Cytometer SYSTEM II Software
Medical device recall Z-0472-2019. Published in FDA’s Enforcement Report on Nov 28, 2018.
- FDA Class I
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Nov 28, 2018. Copied from openFDA on Oct 20, 2026.
- Class I FDA’s most serious class (needs attention)
- Terminated its status, in FDA’s file
- Nationwide FDA’s word, and 1 state named
- 2549 how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class I, the most serious of FDA’s three classes.
“Dangerous or defective products that predictably could cause serious health problems or death. Examples include: food found to contain botulinum toxin, food with undeclared allergens, a label mix-up on a lifesaving drug, or a defective artificial heart valve.”
openFDA, in plain words, its enforcement report fields.
“Class I is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.”
FDA’s rule, 21 CFR 7.3(m)(1), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
COULTER EPICS XL Flow Cytometer COULTER EPICS XL-MCL Flow Cytometer SYSTEM II Software
2549, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
EPICS Catalog Number: EPICS CL 3 COLOR W/MCL 220V 6604985 XL 4CLR FLOW CENTRE 220V AC 6605465 PKG; 4 COLOR XL M/M (220V) 6605465R XL-MCL 4 CLR FLOW CENTRE 220V A 6605437 XL-MCL 4 CLR FLOW CENTRE 240V AC 6605438 XL-MCL 4 CLR FLOW CENTRE…
Every code shown here, 1,101 characters
EPICS Catalog Number: EPICS CL 3 COLOR W/MCL 220V 6604985 XL 4CLR FLOW CENTRE 220V AC 6605465 PKG; 4 COLOR XL M/M (220V) 6605465R XL-MCL 4 CLR FLOW CENTRE 220V A 6605437 XL-MCL 4 CLR FLOW CENTRE 240V AC 6605438 XL-MCL 4 CLR FLOW CENTRE 220V A 6605437R EPICS XL 4 COLORS 115V 6604714 XL-MCL 4CLR FLOW CENTRE 100VAC 6605435 TN, XL Flow Cytometer 100-240V, 50/60Hz 626551 EPICS XL 3 COLOR 230V 6604726 EPICS XL 4 CLR/ MCL 115V 6604988 EPICS XL 4 CLR/ MCL 220V 6604989 XL 4CLR FLOW CENTRE 240VAC 6605466 R-EPICS XL 3 COLOR 115V 6604713 XL 4 CLR W/FLOW 1 YR WARR 6605464 PKG;4 COLOR XL M/M (100V) 6605463 EPICS XL 4 COLOR 220V 6604723 TN, XL/MCL Flow Cytometer 100-240V, 50/60Hz 626552 EPICS XL 3 COLOR 240V 6604725 EPICS XL 4 CLR/MCL 240V 6604990 4 CLR,MCL,MM(120V)REFURB 6605436R XL-MCL 4 CLR FLOWCENTRE 240VAC 6605438R 4 COLOR XL M/M (120V)REFURB 6605464R XL 4CLR FLOW CENTRE 240VAC 6605466R 4 CLR, MCL, MM PKG (240V) 6605438U XL-MCL 4 CLR W/FLOW (RECOND) 6605436U All products manufactured affected for the time period: FC-500 From 01/22/2002 to 01/31/2018 EPICS XL/XL-MCL From 11/01/1992 to 03/15/2013
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Worldwide distribution. US Nationwide including Puerto Rico. OUS: FC 500: Japan, South Korea, China, Italy, Spain, United Kingdom, Germany, Bangladesh, Czech Republic, France, Pakistan, India, South Africa, Austria, Saudi Arabia, Algeria, Turkey, Belgium, Netherlands, Bulgaria, Sweden, Australia, Hungary, Sri Lanka, Uruguay, Canada, New Zealand, Switzerland, Gabon, Portugal, Mexico, Singapore, Monaco, Hong Kong, Guadeloupe, Zambia, United Arab Emirates, Ireland, Reunion, Poland, Egypt, Slovakia, Croatia, Brazil, Chile, Bahrain, Slovenia, Bosnia and Herzegovina, Greece, Myanmar, Morocco, Serbia, Philippines, Lebanon, Romania, Moldova, Qatar, Barbados, Iraq, Oman, Namibia, Indonesia, Thailand, The Bahamas, Macau, El Salvador, Panama, Denmark, Venezuela, Azerbaijan, Israel, Colombia, Peru, Malaysia, Vietnam, Tunisia, Kuwait, Kenya, Libya, Latvia, Russia, Belarus, Ukraine, Kazakhstan, Taiwan EPICS XL: Albania, Algeria, Angola, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Botswana, Bulgaria, Burundi, Cameroon, Canada, China, Congo, Croatia, Cyprus, Czech Republic, Denmark, Dominican, Republic, Egypt, Ethiopia, France, Germany, Greece, Guinea, Guinea-Bissau, Hong Kong, India, Indonesia, Ireland, Israel, Italy, Japan, Kazakhstan, Kenya, Kuwait, Lebanon, Lesotho, Libya, Macau, Malawi, Mexico, Morocco, Mozambique, Namibia, Netherlands, New Zealand, Nigeria, Oman, Pakistan, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Swaziland, Sweden, Switzerland, Syria, Taiwan, Tanzania, The Bahamas, Tunisia, Turkey, Turkmenistan, Uganda, Ukraine, United Arab Emirates, United Kingdom, Zambia, Zimbabwe
The states and territories these words name
- Puerto Rico
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Jan 12, 2018.
- FDA classified it on Nov 20, 2018.
- FDA’s Enforcement Report published it on Nov 28, 2018.
- FDA terminated it on Apr 30, 2024.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Beckman Coulter Inc., of Brea, CA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: E-Mail.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.