FDA CLASSIFIES FIELD ACTION RELATED TO FC 500™ AND EPICS® AS CLASS 1 RECALL
Beckman Coulter Life Sciences Committed to Helping Customers Take Prompt, Appropriate Actions
(MIAMI – November 20, 2018) – Beckman Coulter Life Sciences today announced the previously communicated global voluntary recall launched in January 2018 related to the FC 500™ Series Flow Cytometers (FC 500), COULTER® EPICS® XL™ and COULTER® EPICS® XL-MCL™ Flow Cytometer with System II Software (together referred to as the EPICS) has been classified as Class 1 by the U.S. Food and Drug Administration (FDA).
In a safety notification letter distributed globally on January 9, 2018, Beckman Coulter Life Sciences notified FC 500 and EPICS customers of a potential intermittent or permanent failure of a purchased component on the circuit amplifier boards. This issue has the potential to impact all assays run on the cytometers for any application, including laboratory-developed tests. The potential for circuit amplifier board failure is latent, intermittent, or permanent, and may affect patient results as follows:
- The failure could present itself as an intermittent or sudden signal loss, resulting in absence of data.
- Alternatively, the failure could also present itself as a drift in signal including a sudden upward or downward shift in signal, an upward or downward drift in signal over time, a fluctuating signal, suboptimal compensation, erroneous results on affected parameters, and/or increased coefficients of variation (CV) of Flow-Check beads.
There are no known patient injuries reported to-date.
Beckman Coulter Life Sciences distributed 460 EPICS units in the United States and 2,089 units outside of the United States from July 1993 through April 2012. Both EPICS versions were discontinued in 2011, and are no longer available for sale. Additionally, Beckman Coulter Life Sciences distributed 535 FC 500 units in the United States and 2,580 units outside of the United States since June 2002.
In January 2018, and again in November 2018, customers were notified of this issue and provided instructions for detecting whether their FC 500 and EPICS cytometers were experiencing this latent/intermittent failure by: (1) having all data reviewed by a laboratory professional prior to release of reported results from the lab; (2) monitoring signal integrity during data acquisition via implementing the collection of Time as a parameter through the creation of time vs. parameter plots; and (3) monitoring and reviewing the Time plots for each parameter for consistent Forward Scatter, Side Scatter and all fluorescence data. These instructions apply to all applications, including laboratory-developed tests.
Beckman Coulter Life Sciences is working closely with the FDA on this recall. To further address the risks associated with this issue, the company has implemented, or is in the process of implementing:
- Released and installed a tetraCXP and stemCXP software update that adds the time vs. parameter plots to all (100%) FC 500 cytometers being used by customers.
- Developed a Software Detection Tool software upgrade to aid in detecting this issue for non-Leukosure applications. Software Detection Tool installation will commence November 16, 2018.Beckman Coulter Life Sciences is contacting affected customers to schedule installation of the Software Detection Tool upgrade. In the interim, customers should continue to use the time vs. parameter plots as the primary detection method.
- For customers running the Leukosure application, Beckman Coulter Life Sciences is in the process of proactively replacing circuit amplifier boards. Beckman Coulter Life Sciences will contact affected customers to schedule replacement of circuit amplifier boards. Circuit boards in instruments using the Leukosure application will be replaced by April 30, 2019.
- In the US, Beckman Coulter Life Sciences intends to replace all circuit amplifier boards by February 2020.
- Beckman Coulter Life Sciences has contacted customers through a separate notification letter about the process for retiring these units.
For additional assay-specific actions and information pertaining to the recall, please refer to the revised and updated customer notification letters sent on November 20, 2018 listed below, which are available on our customer relations page.
- FC 500 Series Flow Cytometers
- COULTER EPICS XL and COULTER EPICS XL-MCL Flow Cytometer with System II Software
Adverse reactions or quality problems experienced with the use of these products can be reported to FDA's MedWatch Adverse Event Reporting program:
- Online: Complete and submit a report at www.fda.gov/medwatch/report.htm
- Regular mail or fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.
Additionally, customers or other interested parties can contact Beckman Coulter Life Sciences directly:
- Dedicated service hotlines: North American customers should call 800-369-0333 (United States) or 800-854-8067(Canada). Both numbers are toll-free, and will be staffed Monday through Friday 8 a.m. – 8 p.m. EST. Customers outside North America should call their local service hotline or submit inquiries using the email address provided below.
- Dedicated email address: Customers globally can send questions or information requests to email@example.com.
- Dedicated media contact: Media inquiries can be directed to Chris Suttile, firstname.lastname@example.org