Events

Recall of Access Immunoasay Systems Digoxin 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
    31253
  • Event Risk Class
    Class 2
  • Event Number
    Z-0576-05
  • Event Initiated Date
    2005-02-23
  • Event Date Posted
    2005-03-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-09-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=37505
  • 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
    Enzyme Immunoassay, Digoxin - Product Code KXT
  • Reason
    Variability in results on patient and qc results of 20-25%, high and low.
  • Action
    Letters were sent to customers via UPS overnite, they request that alternative methods be used for patient testing until new material is made available. Customers are requested to ask for replacements using a fax back form.

Device

Access Immunoasay Systems Digoxin Reagent

Manufacturer

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