Events

Recall of Panther(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
    78216
  • Event Risk Class
    Class 2
  • Event Number
    Z-0027-2018
  • Event Initiated Date
    2017-09-15
  • 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=158900
  • 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
    Instrumentation for clinical multiplex test systems - Product Code NSU
  • Reason
    An incorrect incubator was installed on one panther system which potentially led to incorrect aptima combo 2(r) assay (ac2) results.
  • Action
    The customer was notifed of the potential incorrect results via a phone call on September 15, 2017. A customer letter was sent on September 18, 2017. ¿ The notification letter requests the customer to re-test any negative Aptima Combo 2 assay results tested between July 13, 2017  Aug 30, 2017.

Device

Panther(R) System

Manufacturer

Hologic, Inc
  • Manufacturer Address
    Hologic, Inc, 10210 Genetic Center Dr, San Diego CA 92121-4362
  • Manufacturer Parent Company (2017)
    Hologic Inc
  • Source
    USFDA