Events

Recall of Device Recall TetraCXP Software 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
    63161
  • Event Risk Class
    Class 2
  • Event Number
    Z-0035-2013
  • Event Initiated Date
    2012-05-22
  • Event Date Posted
    2012-10-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-10-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=112732
  • 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
    The recall was initiated because beckman coulter has determined that the specimen and prepared sample stability claims stated in the product labeling for tetracxp software and cyto-stat reagents (cd45-fitc/cd4-rd1/cd8-ecd/cd3-pc5 and cd45-fitc/cd56-rd1/cd19-ecd/cd3-pc5) need to be updated for alignment with current standards and clinical decision-making associated with lymphocyte immunophenotyping.
  • Action
    Beckman Coulter sent a Product Corrective Action (PCA) letter dated May 22, 2012, with attached PCA Response Form to all customers who purchased the tetraCXP Software, CYTO-STAT tetraCHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5, CYTO-STAT tetraCHROME CD45-FITC/CD56-RD1/CD19-ECD/CD3-PC5. The letter provides the customers with an explanation of the problem identified and actions to be taken. Customers were informed that the tetraCXP SYSTEM Guide and CYTO-STAT tetraCHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 & CYTO-STAT tetraCHROME CD45-FITC/CD56-RD1/CD19-ECD/CD3-PC5 product labeling will be revised to reflect the updated claims. Customers were instructed to complete and return the enclosed Response form within 10 days. Customers with questions were instructed to contact Beckman Coulter Customer Service at (800) 526-7694 in the US and Canada or contact their local Beckman Coulter representative. For questions regarding this recall call 714-961-4483.

Device

Device Recall TetraCXP Software System
  • Model / Serial
    All tetraCHROME lots manufactured
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and the following countries: Albania Australia Austria Bahrain Bangladesh Barbados Belarus Belgium Bosnia and Herzegovina Bulgaria Burundi Canada Chile China Colombia Croatia Czech Republic Denmark Ecuador El Salvador Finland France French Guiana French Polynesia Germany Greece Guadeloupe Hong Kong India Indonesia Iraq Ireland Israel Italy Japan Kenya Korea, Republic of Kuwait Libyan Arab Jamahiriya Lithuania Macao Malaysia Mexico Monaco Morocco Namibia Netherlands New Zealand Nigeria Norway Oman Pakistan Panama Poland Puerto Rico Qatar Reunion Romania Russian Federation Saudi Arabia Singapore Slovakia Slovenia South Africa Spain Sudan Sweden Switzerland Taiwan Turkey United Arab Emirates United Kingdom Uruguay
  • Product Description
    TetraCXP Software System, Part Number A40051. || Allows simultaneous identification and enumeration of total CD3+, total CD4+, total CD8+, dual CD3+/CD4+, dual CD3+/CD8+ and/or total CD3+, CD19+ and CD3+/CD56+ lymphocyte percentages and absolute counts in whole blood by flow cytometry. The systems also provide the CD4/CD8 ratio when using CD45-FITC/ CD4-RD1/CD8-ECD/CD3-PC5, and total lymphocyte percentage when using CD45-FITC/CD56-RD1/ CD19-ECD/CD3-PC5.
  • Manufacturer
    Beckman Coulter Inc.

Manufacturer

Beckman Coulter Inc.
  • Manufacturer Address
    Beckman Coulter Inc., 250 S Kraemer Blvd, Brea CA 92821-6232
  • Manufacturer Parent Company (2017)
    Danaher Corporation
  • Source
    USFDA