Events

Recall of Active I PTH 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
    56250
  • Event Risk Class
    Class 2
  • Event Number
    Z-0584-2011
  • Event Initiated Date
    2010-04-22
  • Event Date Posted
    2010-12-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-05-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93066
  • 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, parathyroid hormone - Product Code CEW
  • Reason
    The recall was initiated because beckman coulter has confirmed that the stated stability of the dsl-10-8000 i-pth elisa and dsl-8000 i-pth irma assays may not be achieved for the lot numbers affected by the recall. the affected i-pth elisa and the i-pth irma kit lots may produce falsely elevated patient results. internal stability testing showed an average 16% elevation for i-pth elisa lot 99.
  • Action
    Beckman Coulter sent an Urgent Product Corrective Action Letter to their consignees dated June 18, 2010. The letter identified the product, the problem, and the action to be taken. Consignees were instructed to: (1) Discontinue use of all materials provided with I-PTH ELISA kit lot number 992751 and I-PTH IRMA lot numbers 090013, 090121, and 090372. (2) Review historical external quality control results to ensure the assay performance of these lots was within laboratory specifications. Retesting may be necessary if their laboratory uses only the Control materials provided with the I-PTH ELISA and IRMA kits. (3) Abnormal elevated patient results that are obtained with these lot numbers and that are inconsistent with the patient's clinical status should be reviewed in the context of other clinical diagnostic tests. (4) I-PTH ELISA kit lot number 992751 and I-PTH IRMA lot numbers 090013, 090121, and 090372 will no longer be shipped. Due to the calibrator instability recently encountered with DSL-10-8000 I-PTH ELISA and DSL-8000 I-PTH IRMA assays, Beckman Coulter has decided to immediately discontinue these two part numbers. Consignees were asked to share this information with their laboratory staff and retain the notification as part of their laboratory Quality System documentation. Complete and return the enclosed response form within 10 days so Beckman Coulter can be assured that they received this important notification. If they have any unused product the were asked to contact the numbers listed below: (1) In the United States, contact Customer Service at 1-800-526-382.1 (2) Outside of the United States, consignees were asked to contact their local Beckman Coulter Representative Consignees were told to contact DSL Technical Support Center at 1-800-231-7970 in the United States, or their local Beckman Coulter Representative with any questions. For questions regarding this recall call (714) 961-3634.

Device

Active I PTH ELISA
  • Model / Serial
    Lot Numbers: 992751
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA including MD, NY, GA, NJ, CA, MI, TX, PA, IA, and IN. Internationally to Austria, Brazil, China, Colombia, Czech Republic, France, Germany, Hong Kong, India, Japan, Mexico, and the Russian Federation
  • Product Description
    Active I-PTH ELISA, Part Number: DSL-10-8000 || The DSL-10-80000 ACTIVE I-PTH Enzyme-Linked Immunosorbent Assay (ELISA) Kit provides materials for the quantitative measurement of I-PTH in serum or plasma. This assay is intended for in vitro diagnostic use as an aid in the diagnosis of hyperparathyroidism.
  • 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