Events

Recall of Device Recall Coulter LH 500 Series System

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
    55176
  • Event Risk Class
    Class 3
  • Event Number
    Z-1657-2010
  • Event Initiated Date
    2010-02-04
  • Event Date Posted
    2010-05-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-09-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=90220
  • 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
    Counter, differential cell - Product Code GKZ
  • Reason
    Issue 1: the system will substitute or omit the characters # @ [\] ' {i) when the system is configured in a language other than english or chinese. example: using the character @, a substitution in the string '123@456' would result in '123#456' and an omission would result in '123456' issue 2: the system will omit the character ~ regardless of language. impact: there is a potential for specimen.
  • Action
    Beckman Coulter, Inc. issued "Urgent: Product Corrective Action" notifications dated February 12, 2010. Consignees were informed of the affected product and instructed on proper actions. The firm also asked that the enclosed response forms be returned. For further information, contact your local Beckman Coulter Representative or call 1-800-526-7694.

Device

Device Recall Coulter LH 500 Series System
  • Model / Serial
    Product LH500 100V Part number 178832; Product LH500 120V Part number 178833; Product LH500 240V Part Number 178834; All Serial Numbers.
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed Nationwide and Canada.
  • Product Description
    Coulter¿ LH 500 Series System. Beckman Coulter, Inc. Brea, CA. || Quantitative, automated hematology analyzer and leukocyte differential cell counter for in vitro diagnostic use in clinical laboratories.
  • 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