Events

Recall of Device Recall UniCel Dxl Access Immunoassay Systems Reaction Vessels

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
    46362
  • Event Risk Class
    Class 2
  • Event Number
    Z-1108-2008
  • Event Initiated Date
    2007-07-19
  • Event Date Posted
    2008-03-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-05-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=67282
  • 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
    Chemistry Analyzer - Product Code MMI
  • Reason
    Erroneous results - unicel dxl access immunoassay systems reaction vessels have been found to be defective and there is a potential for an increase in signal leading to an erroneous result.
  • Action
    A Product Corrective Action (PCA) letter was mailed on July 19, 2007, to the Customers that received UniCel Dxl Access lmmunoassay System Reaction Vessels lot 1201291 and 1201431. The customers were informed that a small percentage of the reaction vessels (Lot #s: 1201291and 1201431 ) have been found to be defective and there is a potential for an increase in signal leading to an erroneous result. The customers were instructed to discontinue use and discard these lots. A response form was included.

Device

Device Recall UniCel Dxl Access Immunoassay Systems Reaction Vessels
  • Model / Serial
    Part Number: 386167; Lot Code: 1201291 & 1201431
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide & Canada
  • Product Description
    UniCel Dxl Access Immunoassay Systems Reaction Vessels for Use with UniCel Dxl Access Immunoassay Systems, Part Number : 386167, Beckman Coulter, Inc, Brea CA 92822
  • Manufacturer
    Beckman Coulter Inc

Manufacturer

Beckman Coulter Inc
  • Manufacturer Address
    Beckman Coulter Inc, 200 S Kraemer Blvd, Brea CA 92822-6208
  • Source
    USFDA