Events

Recall of MULTIGENT ACETAMINOPHEN ASSAY

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by SEKISUI DIAGNOSTICS P.E.I. 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
    16940
  • Event Risk Class
    II
  • Event Initiated Date
    2015-05-06
  • 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
    Sekisui diagnostics has issued a field correction for the acetaminophen assay catalog number 2k99-20 505-10 and 505-30 because the interference for n-acetylcysteine (nac) has increased (resulting in a larger negative bias in acetaminophen concentration) relative to the level reported in the reagent package insert.

Device

MULTIGENT ACETAMINOPHEN ASSAY
  • Model / Serial
    Model Catalog: 2K99-20 (Lot serial: 46953UQ12); Model Catalog: 2K99-20 (Lot serial: 46207UQ09); Model Catalog: 2K99-20 (Lot serial: 46561UQ08); Model Catalog: 2K99-20 (Lot serial: 46121UQ07); Model Catalog: 2K99-20 (Lot serial: 45797UQ04); Model Catalog: 505-30 (Lot serial: 46098); Model Catalog: 505-10 (Lot serial: 46098); Model Catalog: 505-30 (Lot serial: 45844); Model Catalog: 505-10 (Lot serial: 45844); Model Catalog: 505-30 (Lot serial: 46358); Model Catalog: 505-10 (Lot serial: 46358); Model Catalog: 505-30 (Lot serial: 45468); Model Catalog: 505-10 (Lot serial: 45468)
  • Product Description
    Muligent Acetaminophen Assay
  • Manufacturer
    SEKISUI DIAGNOSTICS P.E.I. INC.

Manufacturer

SEKISUI DIAGNOSTICS P.E.I. INC.