Events

Recall of Device Recall IMMAGE Immunochemistry Systems

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
    57750
  • Event Risk Class
    Class 2
  • Event Number
    Z-2045-2011
  • Event Initiated Date
    2010-08-24
  • Event Date Posted
    2011-04-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-06-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97319
  • 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 and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
  • Extra notes in the data
    Reagent, general purpose - Product Code LDT
  • Reason
    The recall was initiated because beckman coulter has confirmed an immage¿ systems wash solution lot 71744 was manufactured by a beckman european facility and not intended to be used in the u.S. however, this lot was inadvertently shipped to the u.S. and delivered to five customers.
  • Action
    The firm, Beckman Coulter, contacted the customers who received the IMMAGE Immunochemistry Systems Wash Solution, lot #71744 by telephone. Beckman sent a follow-up "URGENT: PRODUCT CORRECTIVE ACTION" letter dated August 25, 2010, to all affected customers. The letter described the product, problem and actions to be taken. The customers were instructed to discontinue use of Immage¿ Immunochemistry Systems Wash Solution lot 71744; return the material to Beckman Coulter's Chino warehouse: Beckman Coulter Inc., 15989 Cypress Ave, Chino, CA 91710, Phone: 909-597-3967; package the material the way it arrived and use Beckmans internal Fedex account to ship the material; complete and return an enclosed FAX BACK RESPONSE FORM within 10 days via fax to (714) 961-4234 or mail to: Beckman Coulter, Inc., Attn: Regulator Affairs, 250 S. Kraemer Blvd, Brea, California 92821, Mail code E2.Se.08; share this information with laboratory staff; retain the notification as part of their Quality System documentation, and provide a copy of the letter if they forwarded the affected products. If you have any questions regarding this letter, please call Beckmans Customer Support Center (Hotline) at (800) 854-3633 in the United States and Canada.

Device

Device Recall IMMAGE Immunochemistry Systems
  • Model / Serial
    Lot Numbers: 71744
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Distribution
    Nationwide distribution: USA including states of : AL, CA, MI and IN.
  • Product Description
    IMMAGE¿ Immunochemistry Systems Wash Solution Part Number: 447060 || The IMMAGE¿ Immunochemistry Systems Wash Solution is intended for use with IMMAGE¿ Immunochemistry Systems and reagents for the quantitative determinations of components in biological fluids. The Beckman Coulter IMMAGE¿ Immunochemistry System is a fully automated, computer controlled, bench-top analyzer designed for the in vitro quantitation of biological fluid components and therapeutic drugs. The system methodologies are rate turbidimetry and rate nephelometry.
  • 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