Events

Recall of Device Recall Sex Hormone Binding Blobulin (SHBG) 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
    56416
  • Event Risk Class
    Class 2
  • Event Number
    Z-0431-2011
  • Event Initiated Date
    2010-07-26
  • Event Date Posted
    2010-11-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-05-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93597
  • 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
    Radio immunoassay, tetosterone and dihydrotestosterone - Product Code CDZ
  • Reason
    The recall was initiated because the instruction for use (ifu) for access shbg does not specify the units of measure to be used when calculating the free androgen index (fai %). access shbg (nmol/l) values and access testosterone (ng/ml) values are reported in different default units. the testosterone value (when reported in ng/ml) requires conversion to nmol/l before the fai % can be calculated.
  • Action
    Beckman Coulter sent an Urgent Product Corrective Action (PCA) letter on the week of July 26, 2010 to the affected customers. The letter was dated July 30, 2010, and identified the product, the problem and provided the appropriate equation to recalculate the FAI% values. The customers were asked to share this information with their laboratory staff and retain the notification as part of their laboratory Quality System documentation. Customers were also asked to complete and return the enclosed response form within 10 days to confirm that they had received the important notification. The customers were instructed to contact Beckman Coulter Technical Support at 1-800-854-3633 in the United States, or contact their local Beckman Coulter Representative if they had any questions regarding the notification.

Device

Device Recall Sex Hormone Binding Blobulin (SHBG) Reagent
  • Model / Serial
    Lot Numbers:009046, 010202, 829586, 909837, 914557, 915628,  917613, 919184
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA including AL, AR, CA, CO, FL, GA, IL, IN, LA, MA, MI, MN, MO, MS, NC, NE, NV, NY, OH, OK, OR, TN, TX, UT, VA, WA, AND WI and the country of Canada
  • Product Description
    Sex Hormone Binding Globulin (SHBG) Reagent for use on Access Immunoassay Systems, Part number(s): A48617 || The Access SHBG assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of Sex Hormone Binding Globulin levels in human serum and plasma using the Access Immunoassay Systems.
  • 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