Reported Nov 28, 2018 · Terminated
1) Cytomics FC 500 With CXP Software BECKMAN COULTER 2) Cytomics FC 500 MPL With MXP Software BECKMAN COULTER flow…
Beckman Coulter Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Beckman Coulter Inc. · 250 S Kraemer Blvd · Brea, CA · 92821-6232
Is this the product you have?
- 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
- Lot codes and dates
- 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 periodFC-500 From 01/22/2002 to 01/31/2018 EPICS XL/XL-MCL From 11/01/1992 to 03/15/2013
- Amount recalled
- 3115
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
- PR
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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