Severity
Critical
CriticalClass ITerminated
FDA Devices recall · Reported November 28, 2018
COULTER EPICS XL Flow Cytometer COULTER EPICS XL-MCL Flow Cytometer SYSTEM II Software
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 plo…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Beckman Coulter Inc. recalled COULTER EPICS XL Flow Cytometer COULTER EPICS XL-MCL Flow Cytometer SYSTEM II Software - a critical-severity action.
COULTER EPICS XL Flow Cytometer COULTER EPICS XL-MCL Flow Cytometer SYSTEM II Software was recalled by Beckman Coulter Inc. in November 28, 2018. Reason: A manufacturing defect on the amplifier board of the Flow Cytometers my cause signal loss and/or signal drift…. Check the official notice for the remedy. Verify recall #Z-0472-2019 with the FDA Devices before acting.
The recall
Beckman Coulter Inc. issued this critical-severity FDA Devices recall-A manufacturing defect on the amplifier board of the Flow Cytometers my cause signal loss and/or signal drift….
- Critical
- severity level
- 3K units
- affected scope
- Class I
- classification
- November 28, 2018
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0472-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0472-2019) was formally reported on November 28, 2018, with the manufacturer initiating the action on January 12, 2018. It is classified under Critical severity (Class I), with a current status of Terminated. Beckman Coulter Inc. is listed as the recalling firm, operating out of Brea, CA. Federal records list the affected scope as 2549.
The documented reason for this recall is: 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… Distribution data in the federal record shows the product reached: 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, Austri…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,422 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
2549
Related Recalls
6
0 from same agency
Product description
COULTER EPICS XL Flow Cytometer COULTER EPICS XL-MCL Flow Cytometer SYSTEM II Software
Reason for recall
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | Z-0472-2019 |
| Date reported | November 28, 2018 |
| Date initiated | January 12, 2018 |
| Recalling firm | Beckman Coulter Inc. |
| Firm location | Brea, CA |
| Affected scope | 2549 |
| Distribution | 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, Alg… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0472-2019) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
COULTER EPICS XL Flow Cytometer COULTER EPICS XL-MCL Flow Cytometer SYSTEM II Software. Recalled by Beckman Coulter Inc.. Units affected: 2549.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 28, 2018. Severity: Critical. Recall number: Z-0472-2019.
Where was the recalled product distributed? ▼
Distribution: 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.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0472-2019) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported November 28, 2018. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.