Events

Recall of Device Recall PerkinElmer 226 Sample Collection Device

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
    77668
  • Event Risk Class
    Class 3
  • Event Number
    Z-2756-2017
  • Event Initiated Date
    2017-05-31
  • Event Date Posted
    2017-07-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-07-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=157403
  • 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
    Newborn screening specimen collection paper - Product Code PJC
  • Reason
    Perkinelmer 226 sample collection devices lot number 317114 had serial numbers printed on the pack labels that did not match the serial number range of the devices contained within the pack.
  • Action
    PerkinElmer sent an Urgent Medical Device Correction letter dated May 30, 2017, to the sole consignee. PerkinElmer requested the consignee implement the following actions: 1. Discontinue use of the pack label to track the device serial numbers distributed to your sample submitters. 2. Verify submitter of devices received without provider information prior to demographic entry. 3. Verify the serial number of the pack label matches the device serial numbers within the pack of your undistributed inventory prior to distributing to your sample submitter or, 4. Return undistributed inventory to PerkinElmer for inspection , and rework if required. For further questions please call (864) 299-8787.

Device

Device Recall PerkinElmer 226 Sample Collection Device
  • Model / Serial
    lot numbers 317113 and 317114
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution to the state of : AL
  • Product Description
    PerkinElmer 226 Sample Collection Device || The PerkinElmer 226 Sample Collection Device is intended to be used as a medium to collect and transport whole blood specimen spots to a laboratory in Newborn Screening.
  • Manufacturer
    PerkinElmer Health Sciences, Inc.

Manufacturer

PerkinElmer Health Sciences, Inc.
  • Manufacturer Address
    PerkinElmer Health Sciences, Inc., 17 P & N Drive, Greenville SC 29611
  • Manufacturer Parent Company (2017)
    Perkin Elmer Inc.
  • Source
    USFDA