Z-0471-2019 Class I Terminated
FDA device recall Z-0471-2019 was initiated by Beckman Coulter Inc. on Jan 12, 2018 and is designated Class I. 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… The recall status is terminated (terminated Apr 30, 2024). Affected quantity: 3115.
Recall Details
- Product Type
- Devices
- Report Date
- Nov 28, 2018
- Initiation Date
- Jan 12, 2018
- Termination Date
- Apr 30, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3115
Product Description
Reason for Recall
Distribution Pattern
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
Code Information
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0471-2019
- openFDA file date
- Oct 6, 2026
- Loaded by RegDataLab
- Oct 12, 2026