The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
- Recalled Product: FC500 Series Flow Cytometers and EPICS XL Series Flow Cytometers
- Product Lot Numbers:
- FC500 Series Flow Cytometers:
- FC500™ Flow Cytometer MCL PN: 626553; 6605627; 6605628; 6605629;6605630; A89264; A89151; A88262; A88263
- FC500™ Flow Cytometer MPL PN: 626554
- EPICS XL Series Flow Cytometers:
- Epics Cl 3 Color W/Mcl 220v Pn6604985
- Epics Xl 4clr Flow Centre 220V AC: 6605465; 6605465R; 6605437; 6605438; 6605437R; 6604714; 6605435; 626551; 6604726; 6604988; 6604989; 6605466; 6604713; 6605464; 6605463; 6604723; 626552; 6604725; 6604990; 6605436R; 6605438R; 6605464R; 6605466R; 6605438U; 6605436U
- FC500 Series Flow Cytometers:
- Distribution Dates:
- FC500 Series Flow Cytometers: June 2002 through February 2018
- EPICS XL Flow Cytometers: July 1992 through April 2012
- Devices Recalled in the U.S.:
- 535 FC500 Flow Cytometers and 460 EPICS XL Flow Cytometers
The FC500 Series Flow Cytometers and EPICS XL Series Flow Cytometers are used to simultaneously analyze multiple characteristics of thousands of individual cells in a relatively short period of time. These devices can be used to diagnose and monitor conditions, like blood cancers, and other blood disorders, and for immune monitoring in HIV patients and other immunocompromised patients.
The FC500 Series Flow Cytometers and EPICS XL Series Flow Cytometers are also used to count white blood cells in leukocyte-reduced blood products and to count CD34+ stem cells for FDA licensed cord blood products and other cellular products intended for stem cell transplantation.
Reason for Recall
Beckman Coulter Life Sciences is recalling 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.
Who May be Affected
- Laboratory personnel who perform clinical testing using patient samples on the affected cytometers
- Laboratory personnel who are preparing stem cell transplantation and licensed cord blood products
- Health care providers who interpret these clinical test results
- Patients being tested with the FC500 Series Flow Cytometers and EPICS XL Series Flow Cytometers
What to Do
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.
Customers or distributors with questions regarding this recall may contact Beckton Coulter Life Sciences by phone at 800-369-0333 or email at LScustomerLetter@Beckman.com Monday - Friday 8:00 am Eastern Standard time - 8:00 pm Eastern Standard Time.
Date Recall Initiated
October 9, 2018
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX to 1-800-FDA-0178.