Events

Recall of 862.2160 Discrete photometric chemistry analyzer

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
    30395
  • Event Risk Class
    Class 2
  • Event Number
    Z-0371-05
  • Event Initiated Date
    2004-10-29
  • Event Date Posted
    2004-12-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-03-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=35798
  • 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
    Beckman coulter has confirmed reports of rare occurrences of unicel dxl 800 access immunoassay systems reaction vessels that are deformed or flattened in their packaging bags for lot 04250160. deformed or flattened rvs could present a rish of causing jams on the unicel exl 800 access immunoassay systems that may require service intervention and could compromise sample analysis.
  • Action
    All customers that were shipped lot 042500160 of the reaction vessels were contacted via telephone (or via on-site visit - Canada only) October 29 - November 1, 2004. A Product Correction Action Letter dated November 2,2 004, sent via U.S. mail to all customers, once contacted by phone with fax back forms.

Device

862.2160 Discrete photometric chemistry analyzer
  • Model / Serial
    Part Number: 386167 Lot Number: 04250160
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    FL, HI, IL, MS, MI, NC, NY, OH, OK, TX, UT, VA, WI, and Canada
  • Product Description
    UniCel Dxl 800 Access Immunoassay Systems (Reaction Vessels).
  • Manufacturer
    Beckman Coulter Inc

Manufacturer

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