![]() ![]() ![]() The failure could present itself as an intermittent or sudden signal loss, resulting in absence of data.The potential for circuit amplifier board failure is latent, intermittent, or permanent, and may affect patient results as follows: This issue has the potential to impact all assays run on the cytometers for any application, including laboratory-developed tests. 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. FC 500™ Series Flow Cytometers (FC 500), COULTER® EPICS® XL™ and COULTER® EPICS® XL-MCL™ Flow Cytometer with System II Softwareīeckman 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.
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