Events

Field Safety Notices about LIFECODES LifeScreen Deluxe (LMX)

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 Transplant 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
    2016-04-22
  • 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 quality control criteria in the lmx product insert (pi) require lmnc to have a negative reported result for all beads. therefore, a false positive result with lmnc invalidates the assay run, and requires the assay to be repeated. we recently identified that the negative control serum (lmnc lot 3003269, expiration date: 12-15-2017), provided with lifecodes lifescreen deluxe (lmx) lot 3003351, may occasionally demonstrate false positive reactivity. internal investigation identified this performance issue to be related to the interaction between lmnc, lmx beads, and conjugate in this particular lot. .

Device

LIFECODES LifeScreen Deluxe (LMX)

Manufacturer

Immucor Transplant Diagnostics, Inc.
  • Manufacturer Parent Company (2017)
    Grifols Sa
  • Source
    AMPMDRS