Events

Recall of Active Prolactin 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
    55154
  • Event Risk Class
    Class 2
  • Event Number
    Z-2047-2011
  • Event Initiated Date
    2009-08-03
  • Event Date Posted
    2011-04-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-04-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=90159
  • 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, prolactin (lactogen) - Product Code CFT
  • Reason
    The recall was initiated because beckman coulter has confirmed that the active prolactin ellisa kit, lot number 890291 over estimates the expected dose values for patient serum samples due to a shift in the assigned calibrator values. beckman coulter recommends that patient results generated with the affected lot be evaluated in the context of other diagnostic tests and the clinical presentatio.
  • Action
    The firm, Beckman Coulter, sent an "URGENT: PRODUCT CORRECTIVE ACTION" Letter dated August 03, 2009 to its customers. The letter describes the product, problem and actions to be taken. The customers were instructed to do the following: Action/Resolution: Discontinue use and discard remaining product with lot number 890291 of Active Prolactin reagents. Contact Beckman Coulter at 1-800-231-7970 for replacement product. Newer lots (lot number 991210 or higher) of the product have been realibrated to restore the performance as described in the Instructions for Use (IFU). For method correlation information, they were told to contact Technical support at the phone number listed below. Consignees were asked to share this information with their laboratory staff and retain this letter for their Quality System documentation and asked to complete and return the enclosed response form within 10 days via fax to: 786-639-4000 so that Beckman can be assured that they received the notification. If you have any other questions regarding this notification, please contact DSL Technical Support Center at 1-800-231-7970 in the United States and Canada , or contact their local Beckman Coulter Representative.

Device

Active Prolactin ELISA
  • Model / Serial
    Lot Number: 890291
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide distribution: USA including states of: FL, GA and NC.
  • Product Description
    Active Prolactin ELISA, 96 Wells, DSL-10-4500 || The DSL-10-4500 Active Prolactin Enzyme-Linked Immunosorbent Assay (ELISA) Kit provides materials for the quantitative measurement of prolactin in human serum. This assay is intended for in vitro diagnostic use in the diagnosis and treatment of disorders of the anterior pituitary gland or of the hypothalamus portion of the brain.
  • 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