medical Class I Updated 2018-11-28

Beckman Coulter Inc. recalls 1) Cytomics FC 500 With CXP Software BECKMAN COULTER 2)

Recalled Product

1) Cytomics FC 500 With CXP Software BECKMAN COULTER 2) Cytomics FC 500 MPL With MXP Software BECKMAN COULTER flow cytometer for in vitro diagnostics

Hazard / Issue

A manufacturing defect on the amplifier board of the Flow Cytometers my cause signal loss and/or signal drifting resulting in absence of data or a population shift in the data plots. This can impact patient results for any application.

Issued by

FDA

Distribution: Nationwide (United States)

Lot/Code Info: FC 500 Catalog Num FC 500" Flow Cytometer MCL with UPS 626553 FC 500" Flow Cytometer MPL 626554 FC 500" MCL Flow Cytometer 5 Color (100V) 6605627 FC 500" MCL Flow Cytometer 5 Color (120V) 6605628 FC 500" MCL Flow Cytometer 5 Color (220V) 6605629 FC 500" MCL Flow Cytometer 5 Color (240V) 6605630 FC 500 Flow Cytometer, Remfg Assy, 5 Clr (220V) A89264 FC 500" Flow Cytometer 100-240V, 50-60HZ, Remfg Assy A89151 FC 500 Recond MCL UPS Flow Cytometer 100-240V, 50-60HZ A88262 FC 500 Flow Cytometer 100-240V A88263 All products manufactured affected for the time period: FC-500 From 01/22/2002 to 01/31/2018 EPICS XL/XL-MCL From 11/01/1992 to 03/15/2013

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