Events

Field Safety Notices about Cryptococcal Antigen Lateral Flow 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 IMMY.

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
    2017-01-04
  • 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
    The affected lots’ negative predictive value remains unchanged and is nearly 100%. it is only the positive predictive value that is affected. thus, you may choose to continue to use the affected lots to report negative results and perform alternative confirmatory testing on all positive specimens. however, there are risks associated with this choice. the crag lfa is the most sensitive, commercially-available test for cryptococcal antigen. the risk associated with confirming all positive specimens with a less sensitive test is that true, low titer specimens may be negative using a less sensitive test method. thus, a true, low titer positive specimen may be incorrectly reported as negative. clinical evidence must be used in conjunction with test results. .

Device

Cryptococcal Antigen Lateral Flow Assay
  • Model / Serial
    161028142817JH, 161019161504NZ, 161013081750KH, 161003112913JG, 161007110553JG, and 161010145035NZ
  • Manufacturer
    IMMY

Manufacturer

IMMY