Events

Recall of Device Recall Beckman Coulter, COULTER LH 750

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
    30732
  • Event Risk Class
    Class 2
  • Event Number
    Z-0536-05
  • Event Initiated Date
    2004-12-16
  • Event Date Posted
    2005-02-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-04-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=36473
  • 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
    A rare risk of sample misidentification exists with coulter lh 750 hematology analyzers. the printout results from the instrument are affected; however, the results stored in the workstation's database are not affected.
  • Action
    Letter 12/20/04 A rare risk of sample misidentification exists with Coulter LH 750 Hematology Analyzers. The printout results from the instrument are affected; however, the results stored in the workstation''s database are not affected. If the LH750 instrument displays a pop-up winder titled Database Error (XXXXXX) and text similar to (Microsoft) (ODBC SQL...) As soon as possible, call Beckman Coulter Customer Service, 800-526-7694) or contact your local rep, to schedule a service call. Do not acknowledge the error. Instead, restart the entire system by completely powering it OFF and then ON. Or, if the LH750 Workstation experiences a change in performance, such as screen display freezes, slow response time, or requires frequent resets to continue processing. As soon as possible, call Beckman Coulter Customer Service, 800-526-7694) or contact your local rep, to schedule a service call. Verify the accuracy of all patient reports for the samples until service confirms the performance of system.

Device

Device Recall Beckman Coulter, COULTER LH 750

Manufacturer

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