Events

Recall of Device Recall Genetic Screening Processor (GSP

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
    76165
  • Event Risk Class
    Class 2
  • Event Number
    Z-1107-2017
  • Event Initiated Date
    2017-01-05
  • Event Date Posted
    2017-01-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-08-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=152425
  • 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
    Fluorometer, for clinical use - Product Code KHO
  • Reason
    The firm became aware that the ball bushing axels are defective in the gsp instrument. during exposure to humid conditions, there is a risk that the axle material will corrode. deterioration of the axle can be observed as deposits of corrosion on the defective axles. ball bushing axles may corrode and corrosion particle may cause contamination in the wells or the corrosion will cause movement issues and possibly spillage and causing contamination of the plate wells.
  • Action
    The recall was initiated on January 5, 2017 via email sent through the PerkinElmer Technical Support group located in Akron Ohio. Actions to be taken by user: 1. As instructed in the analyte specific kit inserts, the use of Kit Controls is required to assure the day-to-day validity of results. Patient results should only be reported if control results for the assay meet the laboratorys established criteria for acceptability. 2. If a movement error occurs customers will be directed to contact their local PerkinElmer field service representative. The movement error may indicate deterioration of the axle and therefore the use of the instrument should be avoided until field service personnel have inspected the status of the ball bushing axles or replaced affected ball bushing axles. Actions to be taken by the PerkinElmer: As a corrective action, PerkinElmer will replace the affected ball bushing axles in all the GSP instruments identified in this FSCA/Recall. The replacement may take place either as part of the initial installation activity before the instrument is used, scheduled periodic maintenance, or during a dedicated service visit. This field correction is considered as mandatory by the manufacturer. Customers will be contacted by PerkinElmer to arrange the field service visit.

Device

Device Recall Genetic Screening Processor (GSP
  • Model / Serial
    Serial Numbers: 20210239 20210243 20210244 20210245 20210246 20210247 20210248 20210249 20210250 20210251 20210252 20210253 20210254 20210255 20210256 20210257 20210258 20210259 20210260 20210261 20210262 20210263 20210264 20210265
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    MA, SC, TX, AL OUS: China, Mexico, Peru, Morocco, Italy, Finland, Ecuador, Brazil
  • Product Description
    Genetic Screening Processor (GSP); PerkinElmer Part Number= 2021-0010 || Intended for in vitro quantitative and qualitative determination of analytes in body fluids.
  • 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