Class I Recall of Beckman Coulter Life Sciences FC 500 and EPICS XL Series Flow Cytometers

PUBLISHED: Nov 21, 2018
Relevant to: Ambulatory Care, Clinical Lab, Critical Access Hospitals, Hospitals, Medical Office, Rural Health Clinics

Beckman Coulter Life Sciences is recalling (Class I Recall) the FC500 Series Flow Cytometers and EPICS XL Series Flow Cytometers due to an electrical circuit error that may cause the device's amplifier board to malfunction and produce inaccurate results. This issue has the potential to impact all tests run on the cytometers for any application, including laboratory-developed tests.

No patient injuries have been reported to date, however the use of affected product may cause serious, life-threatening adverse health consequences such as misdiagnosis and improper patient management and treatment for several blood conditions and diseases.

On January 9, 2018 and November 20, 2018, Beckman Coulter Life Sciences notified their customers of this issue through Urgent Recall Notices. The notices asked customers to:

  • Review the notification and distribute the information to all appropriate personnel.
  • Add additional steps to the data analysis processes to help identify the failure of the board of the FC500 Series Flow Cytometers and EPICS XL Series Flow Cytometers by:
  • Having all data reviewed by a laboratory professional prior to release of reported results from the lab.
  • Monitoring signal integrity during data acquisition by implementing the collection of time as a parameter through the creation of time vs. parameter plots.
  • Monitoring and reviewing the time plots for each parameter for consistent forward scatter, side scatter and all fluorescence data.

If laboratory personnel identify unexpected fluctuations in data collection, they should:

  • Reject results of the sample.
  • Stop acquiring samples and immediately contact Beckman Coulter Life Sciences Customer Technical Support Center at (800) 369-0333 to determine if the signal loss is potentially caused by a defective amplifier board. The local Beckman Coulter Life Sciences Representative will gather additional information and schedule an on-site service visit.
  • If the signal loss is suspected, stop using the instrument until the Beckman Coulter Life Sciences Service Engineer arrives.
  • During the on-site service visit, Beckman Coulter Life Sciences Service will inspect the instrument to confirm if amplifier board(s) are defective and replace them.
  • Beckman Coulter Life Sciences is making arrangements to update the system software for auto detection of compromised acquisition data integrity. Customers should continue to monitor signal integrity during data acquisition using time versus parameter plots, in addition to the system software update.
  • Beckman Coulter Life Sciences intends to replace all circuit amplifier boards by February 2020. Replacement of circuit amplifier boards will be done using a risk-based prioritization strategy. This strategy is based on replacing boards in instruments that are being used to make patient management decisions to mitigate any potential harm to patients. Beckman Coulter will replace all the boards in instruments that are being used to run the Leukosure assay by April 30, 2019. Instruments that use Stem Kit will be targeted next for board replacement, followed by ClearLLab, LDTs, and then other assays.

The FDA notes that Laboratory personnel can contact Beckman Coulter to discuss how to conduct a retrospective review of past results. The laboratory's medical director should then consider reviewing past patient results to evaluate if there are any inconsistencies between the flow cytometry results and other laboratory tests or clinical presentation. The laboratory should then contact ordering physicians to discuss retesting of patients, as appropriate.

Licensed cord blood providers and other stem cell transplantation providers should be aware of this issue and ensure that patients receive correct doses of CD34+ stem cell products.

Health care providers who interpret these clinical results should discuss any concerns about the testing process with the clinical laboratory processing their samples and should consider all available clinical information in their treatment decisions. Patients should discuss any concerns with their health care provider.

Follow the link below for additional information and for recalled product lot numbers.

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