Events

Recall of COULTER LH 700 Series

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
    37287
  • Event Risk Class
    Class 2
  • Event Number
    Z-0566-2007
  • Event Initiated Date
    2006-09-12
  • Event Date Posted
    2007-03-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-04-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=50283
  • 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
    Hematology Analyzers - Product Code GKZ
  • Reason
    There is a potential for erroneous yet credible results for body fluids on the lh700 series hematology analyzers when a cassette label fails to read and the subsequent sample is cycled in body fluid mode.
  • Action
    A Product Corrective Action (PCA) letter was mailed on Sep 12, 2006 to all LH 750 accounts to inform them that there is an issue with COULTER LH 700 Series analyzer software that could affect the Body Fluid analysis and that this this anomaly is present only in Software revisions of 2B. The letter instructs the customer on how to determine their software version. Immediate user preventive action was provided in the letter which is to reset the analyzer when a cassette label read error occurs. The letter advises that this information be shared with laboratory staff and be retained as part of their Quality System documentation. A customer response form was also included.

Device

COULTER LH 700 Series
  • Model / Serial
    Part Number 6605632, with 2B Software (2B3, 2B4 and 2B5)
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide and Canada
  • Product Description
    Coulter LH700 Series Hematology Analyzers, Part Number 6605632 with 2B Software (2B3, 2B4 and 2B5)
  • Manufacturer
    Beckman Coulter Inc

Manufacturer

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