Events

Recall of Device Recall PerkinElmer

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Perkinelmer Life 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
    26856
  • Event Risk Class
    Class 3
  • Event Number
    Z-1140-03
  • Event Initiated Date
    2003-07-21
  • Event Date Posted
    2003-08-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2003-11-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=28575
  • 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
    Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control - Product Code DHN
  • Reason
    Product's outer carton label was labeled with an extended expiration date.
  • Action
    PerkinElmer notified customers by telephone on 7/21/2003 of the expiration date error on the outer carton label . A recall letter issued on 7/25/03 and a verification form was requested to be completed and returned.

Device

Device Recall PerkinElmer
  • Model / Serial
    Lot Number: 181578
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    CA, PA, IN, MO Foreign: Switzerland
  • Product Description
    Anti-dsDNA [125I] Radiobinding Assay Kit. For In-Vitro Diagnostic Use || Catalog Number: NEA 103
  • Manufacturer
    Perkinelmer Life Sciences, Inc.

Manufacturer

Perkinelmer Life Sciences, Inc.
  • Manufacturer Address
    Perkinelmer Life Sciences, Inc., 549 Albany Street, Boston MA 02118
  • Source
    USFDA