Events

Recall of Device Recall Cerebrospinal Fluid Test Kit

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
    26227
  • Event Risk Class
    Class 2
  • Event Number
    Z-0973-03
  • Event Initiated Date
    2002-05-16
  • Event Date Posted
    2003-07-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-10-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=27313
  • 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 and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
  • Extra notes in the data
  • Reason
    The csf gels were manufactured incorrectly resulting in irregular wavy bands.
  • Action
    The firm contacted the consignee by telephone on 5/16/2002.

Device

Device Recall Cerebrospinal Fluid Test Kit

Manufacturer

PerkinElmer LIfe Sciences Inc
  • Manufacturer Address
    PerkinElmer LIfe Sciences Inc, 3985 Eastern Rd, Norton OH 44203
  • Source
    USFDA