Class 1 Device Recall Coulter EPICS XL Flow Cytometer/EPICS XLMCL Flow Cytometer

• Date Initiated by Firm: January 12, 2018
• Create Date: November 20, 2018
• Recall Status: Open, Classified
• Recall Number: Z-0472-2019
• Recall Event ID: 81039
• 510(K)Number: K963263 K990172
• Product Classification: Counter, differential cell - Product Code GKZ
• Product: COULTER EPICS XL Flow Cytometer; COULTER EPICS XL-MCL Flow Cytometer; SYSTEM II Software
• Code Information: EPICS Catalog Number: EPICS 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 period: FC-500 From 01/22/2002 to 01/31/2018 EPICS XL/XL-MCL From 11/01/1992 to 03/15/2013
• Recalling Firm/ Manufacturer: Beckman Coulter Inc.; 250 S Kraemer Blvd; Brea CA 92821-6232
• For Additional Information Contact: Aruna Badiga; 305-380-4189
• Manufacturer Reason for Recall: 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.
• FDA Determined Cause: Nonconforming Material/Component
• Action: On 01/12/2018 the firm sent an Urgent Medical Device Recall Letter to affected customers via email/mail informing them that as a result of customer complaints and subsequent internal investigations, Beckman Coulter has determined that an internal electronic component on the circuit Amplifier boards in the FC 500 system may be affected by a manufacturing defect. Each FC 500 system contains seven (7) of the potentially affected Amplifier boards. All instruments are potentially impacted. Customers were informed to implement the following actions for the application used: 1. For All Applications including Laboratory Developed Tests: a. As per the product documentation all data must be reviewed by a laboratory professional prior to the release of reported results from the lab. b. Immediately implement the collection of Time as a parameter and create Time versus Parameter plots which will allow the monitoring of signal integrity during data acquisition as instructed in Attachment 2. c. Review data as described below: i. Review of all Time plots for each parameter. ii. Monitor consistent Forward Scatter, Side Scatter and all fluorescence data over time as shown in Attachment 2. iii. Unexpected fluctuations in the events over time may indicate compromised fluidics, signal integrity or data acquisition conditions. iv. All data must be reviewed prior to the release of any results from the laboratory, via an LIS or any other mechanism. 2. For tetraCXP and stemCXP: a. As it is not possible to add time versus parameter, discontinue use of the automated tetraCXP and stemCXP applications. b. You can continue to use the tetraCHROME reagents and Stem Kit reagents with the manual gating instructions provided in the product labeling. Refer to CYTO-STAT tetraCHROME IFU, PN B90108 (for tetraCHROME CD45- FITC/CD4-RD1/CD8-ECD/CD3-PC5, PN 6607013 and tetraCHROME CD45- FITC/CD56-RD1/CD19-ECD/CD3-PC5, PN 6607073) and the Stem-Kit IFU, PN B6
• Quantity in Commerce: 2549
• Distribution: Worldwide distribution. US Nationwide including Puerto Rico. OUS: FC 500: Japan, South Korea, China, Italy, Spain, United Kingdom, Germany, Bangladesh, Czech Republic, France, Pakistan, India, South Africa, Austria, Saudi Arabia, Algeria, Turkey, Belgium, Netherlands, Bulgaria, Sweden, Australia, Hungary, Sri Lanka, Uruguay, Canada, New Zealand, Switzerland, Gabon, Portugal, Mexico, Singapore, Monaco, Hong Kong, Guadeloupe, Zambia, United Arab Emirates, Ireland, Reunion, Poland, Egypt, Slovakia, Croatia, Brazil, Chile, Bahrain, Slovenia, Bosnia and Herzegovina, Greece, Myanmar, Morocco, Serbia, Philippines, Lebanon, Romania, Moldova, Qatar, Barbados, Iraq, Oman, Namibia, Indonesia, Thailand, The Bahamas, Macau, El Salvador, Panama, Denmark, Venezuela, Azerbaijan, Israel, Colombia, Peru, Malaysia, Vietnam, Tunisia, Kuwait, Kenya, Libya, Latvia, Russia, Belarus, Ukraine, Kazakhstan, Taiwan EPICS XL: Albania, Algeria, Angola, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Botswana, Bulgaria, Burundi, Cameroon, Canada, China, Congo, Croatia, Cyprus, Czech Republic, Denmark, Dominican, Republic, Egypt, Ethiopia, France, Germany, Greece, Guinea, Guinea-Bissau, Hong Kong, India, Indonesia, Ireland, Israel, Italy, Japan, Kazakhstan, Kenya, Kuwait, Lebanon, Lesotho, Libya, Macau, Malawi, Mexico, Morocco, Mozambique, Namibia, Netherlands, New Zealand, Nigeria, Oman, Pakistan, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Swaziland, Sweden, Switzerland, Syria, Taiwan, Tanzania, The Bahamas, Tunisia, Turkey, Turkmenistan, Uganda, Ukraine, United Arab Emirates, United Kingdom, Zambia, Zimbabwe
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = GKZ and Original Applicant = COULTER CORP.