Events

Recall of COULTER Ac"T" 5diff Fix Reagent.

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
    58569
  • Event Risk Class
    Class 2
  • Event Number
    Z-2231-2011
  • Event Initiated Date
    2011-04-08
  • Event Date Posted
    2011-05-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-06-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=99603
  • 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
    Products, red-cell lysing products - Product Code GGK
  • Reason
    The recall was initiated because beckman coulter has confirmed that an issue has been identified with one of the raw materials used to manufacture the coulter a t 5 diff pn 8547171.
  • Action
    Beckman Coulter initiated a Product Corrective Action (PCA) letter on April 8, 2011, with attached PCA Response Form to all customers who purchased the COULTER¿ Ac"T" 5diff Fix Reagent. The letter provided the customers with an explanation of the problem identified and an action to be taken. Customers were instructed to discard the product according to their laboratory safety procedures and use the attached response form to request replacement product. All flagged results should be reviewed as outlined in the Instructions for Use manual and your laboratory protocol. A retrospective review of results is not required if all recommendations for review have been followed as shown in the Instructions for Use. Customers were instructed to share the information with their laboratory staff and to retain the notification as part of their Quality System documentation. If the product was further distirbuted to another laboratory, customers should provide them a copy of the notification letter. The raw material issue has been corrected beginning with COULTER¿ A T 5diff Fix lot 16902E. Customers were instructed to complete and return the enclosed Response Form within ten (10) days. Customers with any questions concerning this notice, were instructed to contact Beckman Coulter Customer Service at 800-526-7694 in the United States or Canada, or contact their local Beckman Coulter representative.

Device

COULTER Ac"T" 5diff Fix Reagent.
  • Model / Serial
    Lot # 16602E, 16702E, 16802E
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of Algeria, Angola, Australia, Botswana, Bulgaria, Czech Republic, Estonia, Finland, France, Germany, Greece, Guyana, Italy, Japan, Kenya, Mexico, Morocco, Namibia, Netherlands, Nigeria, Philippines, Puerto Rico, Russian Federation, Slovakia, South Africa, Switzerland, Taiwan, United Arab Emirates, United Kingdom, Venezuela, and Zambia
  • Product Description
    COULTER¿ Ac"T" 5diff Fix Reagent. || Part Number: 8547171 || COULTER¿ AC"T" 5diff Fix, Instructions for Use, PN 772264. Intended for use as a leukocyte reagent to differentiate subpopulations of cells on COULTER Ac"T 5diff hematology analyzers. Intended for use only with specific Ac"T 5diff reagents. Refer to the instrument product manuals and/or online help, as applicable.
  • 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