Company: Beckman Coulter Life Sciences
Date of Enforcement Report 11/20/2018
Class l:
PRODUCT
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.
Recall Number: Z-0471-2019
REASON
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.
RECALLING FIRM/MANUFACTURER
Beckman Coulter Life Sciences, Brea, CA on 10/9/2018. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
3115
DISTRIBUTION
Nationwide and Internationally