Events

Recall of Device Recall UniCel Closed Tube Aliquotter for UniCel DxC 660i, 680i, 860i and 880i Synchron Access Clinical Sys

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
    63191
  • Event Risk Class
    Class 2
  • Event Number
    Z-0059-2013
  • Event Initiated Date
    2012-07-06
  • Event Date Posted
    2012-10-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-11-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=112909
  • 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
    Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
  • Reason
    The recall was initiated because beckman coulter has confirmed that the current sample syringe pump drive assemblies installed on dxc integrated ystem with unicel closted tube aliquotter (ucta) serial numbers between 547 and 574 may cause a hardware motion error (id0x08000501).
  • Action
    The recall notification was initiated on July 6, 2012 with Beckman Coulter forwarding a Product Corrective Action (PCA) letter with attached PCA Response Form to all customers who purchased the UniCel DxC 880i, UniCel DxC 860i, UniCel 680i, UniCel DxC 660i Clinical System Integrated Workstations UCTA Sample Syringe Pump Drive Assembly. The letter provides the customers with an explanation of the problem identified and an action to be taken. Customers were notified that Beckman Coulter will schedule a Service Call to replace the affected sample syringe pump drive assemblies. Customers were instructed to complete and return the enclosed PCA Response Form within 10 days. Customers with any questions regarding the PCA, were instructed to call Customer Support at (800) 854-3633 in the US and Canada. Outside the US and Canada, customers were instructed to contact Beckman Coulter Representative.

Device

Device Recall UniCel Closed Tube Aliquotter for UniCel DxC 660i, 680i, 860i and 880i Synchron Ac...
  • Model / Serial
    Serial Numbers: 547-574 (UCTA)
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution and US (nationwide) and the countries of China, France, Italy and Taiwan.
  • Product Description
    Unicel Closed Tube Aliquotter (UCTA) for UniCel DxC 660i, UniCel DxC 680i, UniCel DxC 860i, UniCel DxC 880i Synchron Access Clinical Systems. Part Number A45853. || Product Usage: The UniCel DxC Synchron Clinical Systems are fully automated, computer-controlled clinical chemistry analyzers designed for the in-vitro determination of a variety of general chemistries, therapeutic drugs, and other chemistries. Analysis can be performed on serum, plasma, urine, or cerebrospinal fluid (CSF) and whole blood (sample type is chemistry dependent).
  • Manufacturer
    Beckman Coulter Inc.

Manufacturer

Beckman Coulter Inc.
  • Manufacturer Address
    Beckman Coulter Inc., 250 S Kraemer Blvd, Brea CA 92821-6232
  • Manufacturer Parent Company (2017)
    Danaher Corporation
  • Source
    USFDA