Events

Recall of Device Recall PerkinElmer Specimen Gate Screening Center

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by PerkinElmer Life and Analytical Sciences, Wallac, OY.

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
    79421
  • Event Risk Class
    Class 2
  • Event Number
    Z-1541-2018
  • Event Initiated Date
    2017-11-17
  • 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=162274
  • 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
    Potential errors in patient results generated by the screening center product that include both false negative and false positive results.
  • Action
    PerkinElmer sent an Urgent Medical Device Correction letter dated November 14,2017. Instructions: 1. Implement additional control measures concerning demographic information, by taking one of the following actions a. Fully enter demographics before loading specimens on instruments (i.e. specimens can be punched, but the assay plates cannot be loaded to the measurement instruments). b. If the above mentioned is not possible or if previously entered demographic information changes after loading the assay plates on the measurement instruments, recalculate all your results in Specimen Gate laboratory Result Viewer prior to assay acceptance. 2. Follow unreported specimens with available tools to avoid any delay in reporting screening results. For further questions, please call (317) 418-1735

Device

Device Recall PerkinElmer Specimen Gate Screening Center
  • Model / Serial
    All software versions from 1.0 to 1.8 (current software version)
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Distribution to the state of Georgia., and to the countries of : Belgium, Canada, Denmark, Italy, and United Kingdom.
  • Product Description
    Specimen Gate Screening Center, Part Number 5002-0500, All software versions from 1.0 to 1.8 (current software version) || Specimen Gate Screening Center is used for data management of neonatal screening test results and demographics by qualified laboratory personnel in newborn screening programs.
  • Manufacturer
    PerkinElmer Life and Analytical Sciences, Wallac, OY

Manufacturer

PerkinElmer Life and Analytical Sciences, Wallac, OY
  • Manufacturer Address
    PerkinElmer Life and Analytical Sciences, Wallac, OY, Mustionkatu 6, P.O. Box 10, Turku Finland
  • Manufacturer Parent Company (2017)
    Perkin Elmer Inc.
  • Source
    USFDA