Reported Nov 28, 2018 · Terminated
COULTER EPICS XL Flow Cytometer COULTER EPICS XL-MCL Flow Cytometer SYSTEM II Software
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?
- COULTER EPICS XL Flow Cytometer COULTER EPICS XL-MCL Flow Cytometer SYSTEM II Software
- Lot codes and dates
- EPICS Catalog NumberEPICS CL 3 COLOR W/MCL 220V 6604985 XL 4CLR FLOW CENTRE 220V AC 6605465 PKG; 4 COLOR XL M/M (220V) 6605465R XL-MCL 4 CLR FLOW CENTRE 220V A 6605437 XL-MCL 4 CLR FLOW CENTRE 240V AC 6605438 XL-MCL 4 CLR FLOW CENTRE 220V A 6605437R EPICS XL 4 COLORS 115V 6604714 XL-MCL 4CLR FLOW CENTRE 100VAC 6605435 TN, XL Flow Cytometer 100-240V, 50/60Hz 626551 EPICS XL 3 COLOR 230V 6604726 EPICS XL 4 CLR/ MCL 115V 6604988 EPICS XL 4 CLR/ MCL 220V 6604989 XL 4CLR FLOW CENTRE 240VAC 6605466 R-EPICS XL 3 COLOR 115V 6604713 XL 4 CLR W/FLOW 1 YR WARR 6605464 PKG;4 COLOR XL M/M (100V) 6605463 EPICS XL 4 COLOR 220V 6604723 TN, XL/MCL Flow Cytometer 100-240V, 50/60Hz 626552 EPICS XL 3 COLOR 240V 6604725 EPICS XL 4 CLR/MCL 240V 6604990 4 CLR,MCL,MM(120V)REFURB 6605436R XL-MCL 4 CLR FLOWCENTRE 240VAC 6605438R 4 COLOR XL M/M (120V)REFURB 6605464R XL 4CLR FLOW CENTRE 240VAC 6605466R 4 CLR, MCL, MM PKG (240V) 6605438U XL-MCL 4 CLR W/FLOW (RECOND) 6605436U 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
- 2549
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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