Events

Recall of Device Recall UNICEL DXC SYNCHRON SYSTEMS

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Beckman Coulter Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    58022
  • Event Risk Class
    Class 2
  • Event Number
    Z-1972-2011
  • Event Initiated Date
    2010-11-16
  • Event Date Posted
    2011-04-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-06-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=98005
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    UNICEL DXC SYNCHRON SYSTEMS - Product Code JJE
  • Reason
    The hose clamps in the dxc (with serial numbers less than 3412, labeled behind the lower right side instrument door) hydropneumatic system are sharp and pose a possible risk of injury. an operator could be cut by the hose clamps, which could in turn result in increased exposure to any waste products (biohazards) that might be present on the assembly.
  • Action
    The recall communication was initiated with Beckman Coulter forwarding a Product Corrective Action Letter (PCA) dated November 16, 2010 to the affected customers. The recall notice explained the reason for recall and asked that customers take the following actions: (1) Customers with a service contract will have hose clamp covers installed by their Field Service Engineer during the next scheduled Preventive Maintenance (PM). A kit can be ordered through their Customer Service Representative if consignees prefer not to wait for the next Preventive Maintenance visit and (2) Customers without a service contract can obtain a kit by contacting their local Customer Service Representative. Customers were also informed that Kit (PN A68986) containing hose clamp covers and installation instructions is available at no charge from their Customer Service Representatives. One kit is required for each DxC system. The following telephone numbers were given for customers to obtain the kits: (800) 526-3821 (United States) and (800) 463-7828 (Canada). Consignees were asked to share this information with their laboratory staff and retain this notification as part of their laboratory Quality System documentation. If any of the affected product was forwarded on to another laboratory they were asked to provide a copy of this letter to them. Questions are to be directed to Beckman Coulter's Customer Support Center (Call Center) on the Beckman Coulter website at http://www.beckmancoulter.com/customersupport/support or call (800) 854-3633 in the United States and Canada.

Device

Device Recall UNICEL DXC SYNCHRON SYSTEMS
  • Model / Serial
    UniCel DxC Clinical Systems with Serial Number less than 3412 (with serial numbers less than 3412, labeled behind the lower right side instrument door)  UniCel DxC 600 Part #: A10405, UniCel DxC 600 PRO Part #: A11810, UniCel DxC 600i Part #: A27318, UniCel DxC 660i Part #: A64871, UniCel DxC 680i Part #: A64903, UniCel DxC 800 Part #:A11816, UniCel DxC 800 PRO Part #: A11812, UniCel DxC 860i Part #: A64935, and UniCel DxC 880i Part #: A59102  Subsequent Product Codes: CEK, CEO, CFJ, CGA, CGX, CJW, DCK, DLZ, JFL, JFP, JGJ, JGS, JIY, JJE, JXM, LFP, CFR, CDQ, CEM, CGN, CGZ, CHL, DCK, DFT, JFP, JGS, JHI, JIY, JJE, JLW, JMG, JXM, LCD & LCP.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution--United States and countries of Angola, Australia, Belgium, Bulgaria, China, Columbia, Czech Republic, Denmark, Eritrea, Finland, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Kuwait, Latvia, Lebanon, Lithuania, Mexico, Netherlands, Reunion, Serbia, South Korea, Spain, Slovakia, Swaziland, Sweden, Switzerland, Tunisia, Turkey, Taiwan, United Arab Emirates, and the United Kingdom.
  • Product Description
    UniCel DxC Clinical Systems with Serial Number less than 3412 Including: UniCel DxC 600 Part #: A10405, || UniCel DxC 600 PRO Part #: A11810, || UniCel DxC 600i Part #: A27318, || UniCel DxC 660i Part #: A64871, || UniCel DxC 680i Part #: A64903, || UniCel DxC 800 Part #: A11816, || UniCel DxC 800 PRO Part #: A11812, || UniCel DxC 860i Part #: A64935, and || UniCel DxC 880i Part #: A59102.
  • Manufacturer
    Beckman Coulter Inc.

Manufacturer

Beckman Coulter Inc.
  • Manufacturer Address
    Beckman Coulter Inc., 200 S Kraemer Blvd, Brea CA 92821-6208
  • Manufacturer Parent Company (2017)
    Danaher Corporation
  • Source
    USFDA