Events

Recall of Device Recall IMMAGE CReactive Protein (CRP) 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
    48648
  • Event Risk Class
    Class 3
  • Event Number
    Z-0921-2010
  • Event Initiated Date
    2008-01-10
  • Event Date Posted
    2010-03-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-07-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=71801
  • 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
    C-Reactive Protein Antigen, Antiserum, and Control - Product Code DCK
  • Reason
    Immage crp reagent lots m705441, m709279, & m709319, may demonstrate a prozone or hook effect on samples with extremely high crp analyte concentration.
  • Action
    Customers were sent Urgent: Product Corrective Action letters dates, 1/22/2008. The letter identified the issue, discussed the impact, and listed the following actions/resolution. * To eliminate the hook effect when using these lots, run CRP samples beginning with the 1:216 dilution. ~ A limited correlation of patient samples run in the 1:36 dilution compared to the same samples run in the 1:216 dilution verifies acceptable performance (there may be a shift of up to 0.8 mg/dL for samples between 1.0 and 8.0 mg/dL). * Controls run in the 1:216 dilution may recover differently than those run in the default 1:36 dilution. A limited number of control samples were also run in the 1:216 dilution. * The IMMAGE 800 system can be set to default to a non-standard dilution for each chemistry. Change CRP to a Non-Standard Dilution of 1:216 in the Setup section of the software. Detailed instructions for configuring a Non-Standard dilution as default are located in chapter 5 of the IMMAGE 800 Immunochemistry System Operations Manual. * The IMMAGE system does not allow resetting the default dilution of a chemistry. Instructions for running CRP samples beginning in a Non-Standard Dilution are enclosed. * Complete and return the enclosed response form within 10 days so we may maintain our records. Customers are to share this information with their laboratory staff and retain this notification as part of their laboratory Quality System documentation. If you have forwarded any of the affected product listed above to another laboratory, please provide a copy of this letter to them. Questions regarding this letter should be directed to 800-854-3633 or customers can contact their local Beckman Coulter Representative

Device

Device Recall IMMAGE CReactive Protein (CRP) Reagent
  • Model / Serial
    Lots M705441, M709279, M709319
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution -- Including states of AL, CA, CT, DC, FL, FL ,GA, HI, IA, IL ,IN, KY ,MA, MD, ME, MI, MO, NE, NJ, NY, OH, OR, PA, RI, TX, VA, WI, and WV.
  • Product Description
    IMMAGE Immunochemistry Systems C-Reactive Protein (CRP) Reagent, Part Number 447280. || Intended for the quantitative determination of C-Reactive Protein (CRP) in human serum or plasma by rate nephelometry.
  • Manufacturer
    Beckman Coulter Inc

Manufacturer

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