Events

Recall of CF INPLEX ASR CARD

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by GEN-PROBE INCORPORATED DOING BUSINESS AS 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
    14767
  • Event Risk Class
    II
  • Event Initiated Date
    2016-04-01
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    This voluntary recall is being initiated as a result of com15aints of false positive het mutations (9 complaints) and leaking cards (2 complaints) reported to hologic. internal investigations have determined that the false positives and leakage were most likely caused by manufacturing defect at a key component supplier.

Device

CF INPLEX ASR CARD
  • Model / Serial
    Model Catalog: 95-0501 (Lot serial: U35AV); Model Catalog: 95-0501 (Lot serial: U34DB); Model Catalog: 95-0501 (Lot serial: U34CI); Model Catalog: 95-0501 (Lot serial: U34GK); Model Catalog: 95-0501 (Lot serial: U35CI); Model Catalog: 95-0501 (Lot serial: U35CG); Model Catalog: 95-0501 (Lot serial: U34AH)
  • Product Description
    CF InPlex ASR Card
  • Manufacturer
    GEN-PROBE INCORPORATED DOING BUSINESS AS HOLOGIC INC.

Manufacturer

GEN-PROBE INCORPORATED DOING BUSINESS AS HOLOGIC INC.
  • Manufacturer Address
    SAN DIEGO
  • Manufacturer Parent Company (2017)
    Hologic, Inc.
  • Source
    HC