Events

Recall of Device Recall PerkinElmer Life Sciences

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
    26852
  • Event Risk Class
    Class 2
  • Event Number
    Z-1206-03
  • Event Initiated Date
    2003-07-28
  • Event Date Posted
    2003-09-12
  • 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=28563
  • 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, Angiotensin I And Renin - Product Code CIB
  • Reason
    Incorrect calibration standard value may result in 25% higher assay values for controls and patient samples.
  • Action
    PerkinElmer notified all customers who received the lots by telephone by July 23, 2003 followed by letter dated July 25, 2003, which includes instructions for documenting receipt and lot removal either by destroying or returning product to PerkinElmer

Device

Device Recall PerkinElmer Life Sciences
  • Model / Serial
    Lot 181269, Expiration 8/27/03
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    MD, NC, CA, VT, IL, MI, IL, NY, DC, MN, HI, WA, UT Nationwide. International: Belgium, Germany, Israel, UK, Canada, Hugary, Switzerland, Korea
  • Product Description
    Angiotensin I [125I] Radioimmunoassay Kit, 250 Tube || Catalog Number: NEA104 || For in-vitro diagnostic use
  • Manufacturer
    Perkinelmer Life Sciences, Inc.

Manufacturer

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