Events

Field Safety Notices about Pak LxTM Assay

According to Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), this field safety notices involved a device in Slovenia that was produced by Immucor GTI Diagnostics, Inc..

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Date
    2017-01-06
  • Event Country
    Slovenia
  • Event Source
    AMPMDRS
  • Notes / Alerts
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • Extra notes in the data
  • Reason
    We have determined that the conjugate diluent included in these kits has an expiration date defined on its labeling which is outside its supported stability. the expiration date for the conjugate diluent should be one year shorter than that provided on the labels. .

Device

Pak LxTM Assay
  • Model / Serial
    Pak Lx Assay Kit Lot: 3003658 Current Expiration: 2017-03—15 Pak Lx Assay Kit Lot: 3004022 Current Expiration: 2017-05—15
  • Manufacturer
    Immucor GTI Diagnostics, Inc.

Manufacturer

Immucor GTI Diagnostics, Inc.