Field Safety Notices about LABType HD DRB1 Typing Test

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 One Lambda, Inc..

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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.

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  • Type of Event
    Field Safety Notice
  • Event Country
  • Event Source
  • 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
    Notice: the following allele specificities are missing from bead 10 in the lot-specific user documents and catalog file for the labtype hd drb1 typing test (catalog id rssoh2b1, lot 009, batches 001-036) and may cause a mistyping: missing allele specificity potential mistype incorrect lot specific user document/cat file and revision drb1*08:42, drb1*11:29, drb1*11:47, drb1*11:63:01 drb1*16:09:02 samples typed as drb1*08:02:01~02:04 may also be mistyped to drb1*08:42 samples typed as drb1*11:39 may also be mistyped to drb1*11:29 samples typed as drb1*11:151 may also be mistyped to drb1*11:63:01 rsso-h2b1-009-ws3-00; revisions 0-4 rsso-h2b1-009-ws-00; revisions 0-4 rsso-h2b1-009-lim-00; revisions 0-4 rsso-h2b1-009-bpi-00; revisions 0-4 rsso-h2b1-0009-cat-00; revisions 0-4.