Events

Recall of Device Recall IMMAGE IMMUNOCHEMISTRY 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
    55787
  • Event Risk Class
    Class 2
  • Event Number
    Z-2195-2010
  • Event Initiated Date
    2010-05-21
  • Event Date Posted
    2010-08-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-05-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=91778
  • 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
    nephelometer - Product Code JQX
  • Reason
    Beckman coulter is initiating a recall of immage immunochemistry systems buffer 1 (buf1) due to received reports of increased recovery of control and patient samples using the lots of immage buf1. some lots of buf1 have been reported to cause high shifts in recovery of control or patient samples. quality control failures may result after replacing buf1 with a different lot.
  • Action
    Beckman Coulter will send a Product Corrective Action (PCA) letter on the week of April 19, 2010 to the affected customers. The letter provided the customers with an explanation of the problem and a work around.

Device

Device Recall IMMAGE IMMUNOCHEMISTRY SYSTEM
  • Model / Serial
    Lot#s: T908069, T908104, T909110, T001036 ( This lot was not shipped to customers.)
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide: U.S., Canada, Australia, Austria, Belgium, China, Czech Republic, Denmark, France, Germany, Greece, Hong Kong, Iceland, Ireland, Italy, Japan, Liechtenstein, Macao, Malaysia, Netherlands, New Zealand, Norway, Oman, Poland, Qatar, Russian Federation, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Tunisia, Turkey and United Kingdom,
  • Product Description
    IMMAGE Immunochemistry Systems Buffer 1 (BUF1), Part Number: 447650
  • 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