Events

Recall of Device Recall Specimen Gate Screenig Center

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Perkin Elmer 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
    72013
  • Event Risk Class
    Class 2
  • Event Number
    Z-0166-2016
  • Event Initiated Date
    2015-08-24
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=139579
  • 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
    Calculator/data processing module, for clinical use - Product Code JQP
  • Reason
    It would be possible for an abnormal analytical test result value from an affected newborn to be reported with a default result interpretation of normal. the analytical test result value would be correct but the interpretation of the test result value would be incorrect.
  • Action
    Perkin Elmer issued the Recall Letter on 8/24/15 delivered to the customer by email .Software Services will be asked to make sure the customers receive the Recall Letter and implement the recommended corrective measures: Ensure all laboratory routine sample testing procedures are followed to avoid procedural anomalies. In the event a procedure anomaly occurs, review the final analytical result and the corresponding interpretation to confirm both are accurate before releasing the report. Once a PerkinElmer reporting error query is available, continue to run the query until the final corrective action is deployed to your site. The final corrective action will involve an installation update to the software. For further information, please contact your local PerkinElmer representative or specimen.gate.support@perkinelmer.com

Device

Device Recall Specimen Gate Screenig Center
  • Model / Serial
    Software Version 1.6
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US distribution to FL, GA, and NV; and Canada
  • Product Description
    Perkin Elmer Specimen Gate, Screening Center. Data management of neonatal screening test results and demographics by qualified laboratory personnel in newborn screening programs.
  • Manufacturer
    Perkin Elmer Life Sciences Inc

Manufacturer

Perkin Elmer Life Sciences Inc
  • Manufacturer Address
    Perkin Elmer Life Sciences Inc, Laitun 4 Mustionkatu 6, Turku Finland
  • Manufacturer Parent Company (2017)
    Perkin Elmer Inc.
  • Source
    USFDA