Events

Recall of Device Recall RapidfFN for the TLiIQ(R) System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Hologic, 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
    78832
  • Event Risk Class
    Class 2
  • Event Number
    Z-0677-2018
  • Event Initiated Date
    2017-11-29
  • Event Status
    Completed
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=160636
  • 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
    Enzyme immunoassay, fetal fibronectin - Product Code LKV
  • Reason
    Rapid ffn cassettes were manufactured with material (a137 ascites) from a new supplier (sdix). the products were distributed to customers before fda approved the change to use the material from sdix.
  • Action
    Hologic initiated the recall on Wednesday, November 29, 2017. The method of notification was via overnight FedEx.

Device

Device Recall RapidfFN for the TLiIQ(R) System

Manufacturer

Hologic, Inc.
  • Manufacturer Address
    Hologic, Inc., 1240 Elko Dr, Sunnyvale CA 94089-2212
  • Manufacturer Parent Company (2017)
    Hologic Inc
  • Source
    USFDA