Events

Field Safety Notices about LIFECODES HLA-DQA1/B1 Typing Kit

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.

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
    2015-12-30
  • 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 are investigating a single instance of false positive reactivity of probe dqb253 associated with an allele pair of dqb1*03:03:02:01, dqb1*03:04:01. a false positive result causes the exclusion of dqb1*03:03:02:01/ 03:04:01 as a possible allele combination. the risk to the patient is considered low due to the low frequency of this event, and the additional risk reduction achieved through application of the requirements and limitations described in the product insert. results from these kits are not to be used as the sole basis upon which a clinical decision affecting the patient is made. due to the complex nature of hla typing, qualified personnel should review data interpretation and typing assignments, as per the limitations of the procedure section of the product insert. .

Device

LIFECODES HLA-DQA1/B1 Typing Kit
  • Model / Serial
  • Manufacturer
    Immucor

Manufacturer

Immucor
  • Manufacturer Parent Company (2017)
    Grifols Sa
  • Source
    AMPMDRS