Events

Recall of CYTOSTAT tetraCHROME" CD45FITC/CD4RD1/CD8ECD/CD3PC5

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
    57445
  • Event Risk Class
    Class 2
  • Event Number
    Z-1876-2011
  • Event Initiated Date
    2010-09-16
  • Event Date Posted
    2011-04-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-06-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=96249
  • 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
    Differential Cell Counter - Product Code GKZ
  • Reason
    A labeling error resulted in the specimen age stability and the prepared sample stability being stated incorrectly in the instructions for use. there is no impact to the product safety or functionality.
  • Action
    An Urgent: Product Corrective Action letter dated, September 27, 2010, was sent to customers. The letter identified the affected product and stated the reasons for the recall. Customers were also asked to take the following actions: ACTION/RESOLUTION For issue 1: The specimen stability claims should be as follows: - 48 hours for both % positives and absolute counts for the CD45/4/8/3 tube - 24 hours for both % positives and absolute counts for the CD45/56/19/3 tube For Issue 2: Results produced are not impacted when samples are prepared and run within the post collection time frames provided in the product instructions for use: - Preparation within 72 hours of collection for the CD45/4/8/3 tube - Preparation within 24 hours of collection for CD45/56/19/3 tube Beckman Coulter requested consignees complete and return the enclosed response form within 10 days so they may maintain their records. The firm also asked that they share the information with laboratory staff, and retain this notification as part of their Quality System documentation. Questions regarding the Product Corrective Action were directed to (800) 526-7694 in the United States or (800) 463-7828 in Canada. If outside the US or Canada, consignees were instructed to contact their local Beckman Coulter Representative.

Device

CYTOSTAT tetraCHROME" CD45FITC/CD4RD1/CD8ECD/CD3PC5
  • Model / Serial
    All lots since 08/2003
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- United States, Albania, Australia, Bahrain, Bangladesh, Barbados, Belarus, Belgium, Bosnia and Herzegovina, Bulgaria, Burundi, Cameroon, Chile, China, Colombia, Croatia, Czech Republic, Denmark, El Salvador, Finland, France, French Guiana, French Polynesia, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Korea, Republic of Kuwait, Libyan Arab Jamahiriya, Macao, Malaysia, Mexico, Monaco, Morocco, Namibia, Netherlands, New Zealand, Nigeria, Norway, Oman, Pakistan Panama, Poland, Portugal, Puerto Rico, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sudan, Sweden, Switzerland, Turkey, Ukraine, United Arab Emirates, United Kingdom, and Uruguay.
  • Product Description
    CYTO-STAT¿ tetraCHROME" CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5, Part Number: 6607013 || 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-PC5Al.
  • 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