• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 1 Device Recall Beckman Coulter Cytomics FC 500

  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

New Search Back to Search Results
  Class 1 Device Recall Beckman Coulter Cytomics FC 500 see related information
Date Initiated by Firm January 12, 2018
Date Posted November 20, 2018
Recall Status1 Terminated 3 on April 30, 2024
Recall Number Z-0471-2019
Recall Event ID 81039
510(K)Number K030828  K071681  
Product Classification Counter, differential cell - Product Code GKZ
Product 1) Cytomics FC 500 With CXP Software BECKMAN COULTER

2) Cytomics FC 500 MPL With MXP Software BECKMAN COULTER
flow cytometer for in vitro diagnostics
Code Information FC 500 Catalog Num FC 500" Flow Cytometer MCL with UPS 626553 FC 500" Flow Cytometer MPL 626554 FC 500" MCL Flow Cytometer 5 Color (100V) 6605627 FC 500" MCL Flow Cytometer 5 Color (120V) 6605628 FC 500" MCL Flow Cytometer 5 Color (220V) 6605629 FC 500" MCL Flow Cytometer 5 Color (240V) 6605630  FC 500 Flow Cytometer, Remfg Assy, 5 Clr (220V) A89264  FC 500" Flow Cytometer 100-240V, 50-60HZ, Remfg Assy A89151 FC 500 Recond MCL UPS Flow Cytometer 100-240V, 50-60HZ A88262 FC 500 Flow Cytometer 100-240V A88263  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
Recalling Firm/
Beckman Coulter Inc.
250 S Kraemer Blvd
Brea CA 92821-6232
For Additional Information Contact Aruna Badiga
Manufacturer 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.
FDA Determined
Cause 2
Nonconforming Material/Component
Action On 01/12/2018 the firm sent an Urgent Medical Device Recall Letter to affected customers via email/mail informing them that as a result of customer complaints and subsequent internal investigations, Beckman Coulter has determined that an internal electronic component on the circuit Amplifier boards in the FC 500 system may be affected by a manufacturing defect. Each FC 500 system contains seven (7) of the potentially affected Amplifier boards. All instruments are potentially impacted. Customers were informed to implement the following actions for the application used: 1. For All Applications including Laboratory Developed Tests: a. As per the product documentation all data must be reviewed by a laboratory professional prior to the release of reported results from the lab. b. Immediately implement the collection of Time as a parameter and create Time versus Parameter plots which will allow the monitoring of signal integrity during data acquisition as instructed in Attachment 2. c. Review data as described below: i. Review of all Time plots for each parameter. ii. Monitor consistent Forward Scatter, Side Scatter and all fluorescence data over time as shown in Attachment 2. iii. Unexpected fluctuations in the events over time may indicate compromised fluidics, signal integrity or data acquisition conditions. iv. All data must be reviewed prior to the release of any results from the laboratory, via an LIS or any other mechanism. 2. For tetraCXP and stemCXP: a. As it is not possible to add time versus parameter, discontinue use of the automated tetraCXP and stemCXP applications. b. You can continue to use the tetraCHROME reagents and Stem Kit reagents with the manual gating instructions provided in the product labeling. Refer to CYTO-STAT tetraCHROME IFU, PN B90108 (for tetraCHROME CD45- FITC/CD4-RD1/CD8-ECD/CD3-PC5, PN 6607013 and tetraCHROME CD45- FITC/CD56-RD1/CD19-ECD/CD3-PC5, PN 6607073) and the Stem-Kit IFU, PN B6
Quantity in Commerce 3115
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
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = GKZ and Original Applicant = BECKMAN COULTER, INC.