Events

Recall of Device Recall PerkinElmer DELFIA hFSH kit

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by PerkinElmer Health Sciences, 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
    75708
  • Event Risk Class
    Class 3
  • Event Number
    Z-0779-2017
  • Event Initiated Date
    2016-11-16
  • Event Date Posted
    2016-12-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-07-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=151081
  • 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, follicle-stimulating hormone - Product Code CGJ
  • Reason
    A delfia hfsh kit lot failed real time stability testing. the real time stability data demonstrated a decrease in hfsh concentrations between -4.8% to -11.3% for control sera. the -11.3% bias was observed at an hfsh target concentration of 101 iu/l. the change observed in the serum samples within the range 1.76  67.0 iu/l hfsh averaged -2.9%. the reference range of the assay spans 0.60 to 98.0 iu/l.
  • Action
    PerkinElmer initiated recall on November 16, 2016, delivered to the end customer by email facilitated through the PerkinElmer Technical Support group located in Akron Ohio. Technical Support will be asked to make sure the customers receive the Recall Letter and understand the recommended actions. Users asked to inspect inventory, discontinue use destroy the kits and complete the Response Forms and Destruction.Replacement kits will shipped.

Device

Device Recall PerkinElmer DELFIA hFSH kit

Manufacturer

PerkinElmer Health Sciences, Inc.
  • Manufacturer Address
    PerkinElmer Health Sciences, Inc., 940 Winter St, Waltham MA 02451-1457
  • Manufacturer Parent Company (2017)
    Perkin Elmer Inc.
  • Source
    USFDA