For Immediate Release
November 23, 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. (more…)