Events

Recall of Device Recall GENS SlideMaker

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
    48978
  • Event Risk Class
    Class 2
  • Event Number
    Z-0851-2010
  • Event Initiated Date
    2008-05-29
  • Event Date Posted
    2010-02-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-11-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=72446
  • 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
    Automated Slide Stainer - Product Code KPA
  • Reason
    Beckman coulter has become aware of a potential issue in which the sample id information embedded in the barcode affixed to a slide made by the coulter gen*s and lh slidemaker does not match the text.
  • Action
    An Urgent: Product Corrective Action letter, dated June 9, 2008, was sent to customers. The letter identified the affected products, stated the background, discussed the issue, and stated the actions to be taken. Customers are to: 1. Only use upper case alpha characters in the Sample Identifier 2. If you must use lower case alpha characters in the Sample Identifier, configure the SlideMaker Slide labels without a bar-code. Questions regarding the Product Corrective Action should be directed to Beckman Coulter Customer Service at 1-800-526-7694 or your local Beckman Coulter Rep.

Device

Device Recall GENS SlideMaker
  • Model / Serial
    All Software Versions.
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA and Canada.
  • Product Description
    GEN*S SlideMaker, Barcode Label Specifications, GEN*S SM Intended Use, GEN*S Slide and Sample, Part Numbers 6605360, P/N 4237221, 4237212, and 4277299. || Intended for use as an optional peripheral to the COULTER GEN*S System. Creates a blood smear on a clean microscope slide using a segment of the blood sample aspirated by the GEN*S System.
  • Manufacturer
    Beckman Coulter Inc

Manufacturer

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