Events

Recall of Device Recall Inhibin A ELISA

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
    59685
  • Event Risk Class
    Class 3
  • Event Number
    Z-3128-2011
  • Event Initiated Date
    2010-11-10
  • Event Date Posted
    2011-09-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-07-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=103283
  • 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
    Enzyme immunoassay, inhibin-a - Product Code NDR
  • Reason
    The recall was initiated because beckman coulter has confirmed the microbial contamination in the conjugate diluent bottles included in the manual inhibin a elisa kit (part number dsl-10-28100-4), kit lot number 110761.
  • Action
    Beckman Coulter initiated an "URGENT PRODUCT CORRECTION" on June 15, 2011, via a telephone script to the only one customer impacted by the recalled product. The telephone script provided an explanation of the problem identified and the actions to be taken. Beckman Coulter recommended that the customer discontinue use of the recalled product as a preventative measure. Beckman will send a representative to the customer's facility to replace the recalled product in all remaining kits of the affected lot. The customer was instructed to share this information with laboratory staff. For any questions concerning this information, contact Beckman Coulter at 952-368-7874.

Device

Device Recall Inhibin A ELISA
  • Model / Serial
    Lot # 110761
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    (USA) Nationwide Distribution in the state of CA
  • Product Description
    Inhibin A ELISA, Part Number: DSL-10-28100-4 || Product Usage: The Inhibin A ELISA kit is intended for the quantitative measurement of dimeric Inhibin A in human serum or plasma. It is intended strictly for in vitro use as an aid in the diagnosis and monitoring of various hormonal reproductive disorders.
  • Manufacturer
    Beckman Coulter Inc.

Manufacturer

Beckman Coulter Inc.
  • Manufacturer Address
    Beckman Coulter Inc., 250 S Kraemer Blvd, Brea CA 92821-6232
  • Manufacturer Parent Company (2017)
    Danaher Corporation
  • Source
    USFDA