Events

Recall of EMIT II PLUS OPIATES ASSAY

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by SIEMENS HEALTHCARE LIMITED.

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
    128475
  • Event Risk Class
    III
  • Event Initiated Date
    2016-08-19
  • 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
    Siemens investigation confirmed that the introduction of a new syva polyclonal antibody lot (g1) for use in the dimension urine opiates screen has resulted in an alteration of specificity for levallorphan levorphanol nalorphine and oxycodone at the 300 and 2000 ng/ml cutoff concentration. as a result in the change in sensitivity to the cross reactant the claims for these compounds are no longer accurate for either the 300 or 2000 ng/ml cutoff as stated within the instructions for use (ifu). further investigation confirmed that syva beckman coulter and advia chemistry opiate reagents are impacted as well due to a common raw material used in the assays.

Device

EMIT II PLUS OPIATES ASSAY
  • Model / Serial
    Model Catalog: 9B309UL (Lot serial: H5); Model Catalog: DF93A (Lot serial: FA6258); Model Catalog: DF93A (Lot serial: FA7069); Model Catalog: DF93A (Lot serial: GA6324); Model Catalog: DF93A (Lot serial: GB6275); Model Catalog: DF93A (Lot serial: GB7029); Model Catalog: DF93A (Lot serial: GC6160); Model Catalog: 9B309UL (Lot serial: H2); Model Catalog: 9B329UL (Lot serial: H2); Model Catalog: 9B309UL (Lot serial: H3); Model Catalog: K5093 (Lot serial: 16090BB); Model Catalog: K5093 (Lot serial: 16019BA); Model Catalog: K5093 (Lot serial: 15308BA); Model Catalog: K5093 (Lot serial: 15252AF); Model Catalog: K5093 (Lot serial: 15168BA); Model Catalog: K5093 (Lot serial: 15078BB); Model Catalog: 9B329UL (Lot serial: J2); Model Catalog: 9B309UL (Lot serial: J2); Model Catalog: 9B329UL (Lot serial: J1); Model Catalog: 9B309UL (Lot serial: J1); Model Catalog: 9B329UL (Lot serial: H6); Model Catalog: 9B309UL (Lot serial: H6); Model Catalog: 9B329UL (Lot serial: H5); Model Catalog: DF93A (Lot serial: EA6091); Model C
  • Product Description
    EMIT II PLUS OPIATES ASSAY;DIMENSION CLINICAL CHEMISTRY SYSTEM - OPIATES (UOPI);DIMENSION VISTA SYSTEM - URINE OPIATES SCREEN
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

SIEMENS HEALTHCARE LIMITED
  • Manufacturer Address
    OAKVILLE
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    HC