Events

Recall of IGFBP3 IRMA Kit

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
    56485
  • Event Risk Class
    Class 2
  • Event Number
    Z-2607-2010
  • Event Initiated Date
    2010-08-09
  • Event Date Posted
    2010-09-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-08-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93769
  • 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
    Radioimmunoassay, human growth hormone - Product Code CFL
  • Reason
    The recall was initiated after beckman coulter confirmed customer reports that igfbp-3 measurements using igfbp-3 irma kit (ref dsl-6600) lots identified above may result in igfbp-3 levels that are not in agreement with simultaneously measured levels of igf-1. the investigation confirmed that above mentioned lots of igfbp-3 kit provide results elevated by 84% on average. erroneously elevated igf.
  • Action
    The recall communication was initiated with a Product Corrective Action (PCA) letter that was sent on August 09, 2010 to all customers who received the IGFBP-3 IRMA kits, lot numbers referenced. The letter will provide the customers with an explanation of the problem identified and an action to be taken. Customers were instructed to: (1) Discontinue using all lots identified above and discard in accordance with local regulations. (2) To continue testing for IGFBP-3 levels, find an alternate method. (3) Immediately notify all parties of interest (e.g., laboratory staff, clinicians) of the possibility of erroneously elevated IGFBP-3 results for patient samples tested with these lots, and advise all parties that clinical decision making and patient safety may be impacted. (4) Review patient IGFBP-3 results for the lots listed above, and interpret them in the light of additional tests (e.g., IGF-1) and the patient's clinical status and history. Customers were also asked to share the recall information with their laboratory staff and retain this notification as part of their laboratory Quality System documentation. Complete and return the enclosed response form within 10 days. For any questions regarding this notification, customers were to contact the DSL Technical Support Center at 1-800-231-7970 option 4 in the United States, or contact your local Beckman Coulter Representative.

Device

IGFBP3 IRMA Kit
  • Model / Serial
    Lot Numbers: 991017, 991225, 991384, 991694, 991938, 992171, 992372, 992703, 100115A, 100205A, 100205B, 100226A, 100319A, 100409A, 100409B, 100430A and 100521A
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide in US and Canada
  • Product Description
    IGFBP-3 Immunoradiometric Assay (IRMA) Kit, Part || Number: DSL-6600 || usage: The DSL6600 IGFBP-3 immunoradiometric assay (IRMA) kit provides materials for the quantitative measurement of IGFBP-3 in serum. This assay is intended for in vitro diagnostic use.
  • 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