Events

Recall of LABTYPE SSO DQA1/DQB1 TYPING TEST

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by ONE LAMBDA INC.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    107026
  • Event Risk Class
    II
  • Event Initiated Date
    2016-10-13
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Extra notes in the data
  • Reason
    Lot specific user documents and catalog files updated for january 2016 nomenclature contain incorrect allele specificity information for certain beads which may result in mistyping. the impacted worksheets and catalog files were released and available for use between the date period july 29 2016 to august 22 2016. only files analyzed during this period are impacted. contact manufacturer for specific lot #s/batch #s and details.

Device

LABTYPE SSO DQA1/DQB1 TYPING TEST
  • Model / Serial
    Model Catalog: RSO2QT (Lot serial: LOT 010 VARIOUS BATCH #S); Model Catalog: RSSO2Q (Lot serial: LOT 010 VARIOUS BATCH #S); Model Catalog: RSSO2QX (Lot serial: LOT 010 VARIOUS BATCH #S); Model Catalog: RSO2B1T (Lot serial: LOT 010 VARIOUS BATCH #S); Model Catalog: RSSOH2B1X (Lot serial: LOT 010 VARIOUS BATCH #S); Model Catalog: RSSO2B1 (Lot serial: LOT 010 VARIOUS BATCH #S); Model Catalog: RSSOH2B1X (Lot serial: LOT 009 VARIOUS BATCH #S); Model Catalog: RSOH2B1T (Lot serial: LOT 009 VARIOUS BATCH #S); Model Catalog: RSO2B1T (Lot serial: LOT 009 VARIOUS BATCH #S); Model Catalog: RSSOH2B1 (Lot serial: LOT 009 VARIOUS BATCH #S); Model Catalog: RSSO2B1 (Lot serial: LOT 009 VARIOUS BATCH #S); Model Catalog: RSSOH2B1X (Lot serial: LOT 019 VARIOUS BATCH #S); Model Catalog: RSOH2B1T (Lot serial: LOT 019 VARIOUS BATCH #S); Model Catalog: RSO2B1T (Lot serial: LOT 019 VARIOUS BATCH #S); Model Catalog: RSSOH2B1 (Lot serial: LOT 019 VARIOUS BATCH #S); Model Catalog: RSSO2B1 (Lot serial: LOT 019 VARIOUS BATCH #S); Model C
  • Product Description
    LABTYPE SSO CLASS II DQA1/DQB1 TYPING TEST;LABTYPE SSO CLASS II DRB1 TYPING TEST & LABTYPE HD CLASS II DRB1 TYPING TEST;LABTYPE SSO CLASS I BW4 SUPPLEMENT TYPING TEST;LABTYPE SSO MICA
  • Manufacturer
    ONE LAMBDA INC

Manufacturer

ONE LAMBDA INC