Events

Recall of Device Recall LIFECODES PF4 Enhanced assay

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Genetic Testing Institute,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
    64501
  • Event Risk Class
    Class 2
  • Event Number
    Z-1022-2013
  • Event Initiated Date
    2013-02-04
  • Event Date Posted
    2013-03-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-03-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116359
  • 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
    Platelet factor 4 radioimmunoassay - Product Code LCO
  • Reason
    Lifecodes pf4 enhanced assay, lot number 3000389, is being recalled because of observed inconsistent replicate values when testing the kit positive control and patient samples. the variation in reactivity can lead to invalid assays. if an invalid assay is obtained, those results should not be reported and the test should be re-run. an invalid assay would not result in significant harm to a pati.
  • Action
    Hologic/Gen-Probe sent an Urgent Medical Device Recall letter dated February 4, 2013, via FedEx overnight deliver yto all affected customers. The letter identified affected product, stated the issue, and asked that product from the affected lot stop being used. Reported results for all samples tested using the affected lot should be reviewed. The referring physician should be notified that any negative patient result may be erroneous. Remaining inventory should be returned to Gen-Probe. A response form was also asked to be returned. For questions customers were instructed to contact Technical Support at 262-754-1000 or waukeshatechsupport@gen-probe.com. For questions regarding this recall call 262-754-1026.

Device

Device Recall LIFECODES PF4 Enhanced assay
  • Model / Serial
    Kit Lot Number 3000389
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and Internationally to Canada, China, Slovakia, and Spain.
  • Product Description
    Gen-Probe LIFECODES PF4 Enhanced assay, Catalog No. X-HAT45 || GTI PF4 Enhanced is designed as a solid phase enzyme-linked immunosorbent assay (ELISA).
  • Manufacturer
    Genetic Testing Institute,inc

Manufacturer

Genetic Testing Institute,inc
  • Manufacturer Address
    Genetic Testing Institute,inc, 20925 Crossroads Cir Ste 200, Waukesha WI 53186-4054
  • Source
    USFDA