Events

Recall of ADVIA 1200 CHEMISTRY SYSTEM - LACTATE DEHYDROGENASE L-P (LDLP) 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
    34792
  • Event Risk Class
    III
  • Event Initiated Date
    2017-02-13
  • 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
    Siemens healthcare diagnostics is providing an update to all advia chemistry systems lactate dehydrogenase l-p (ldlp) and lactate dehydrogenase p-l (ldpl) assay instructions for use (ifus). the current advia chemistry systems lactate dehydrogenase ifus intended use section contains the following statements which will be removed: advia chemistry ldlp: they may also be used to monitor cancer therapy. advia chemistry ldpl: they may also be used to monitor extensive cancer and cancer therapy. the revised ifu intended use for both assays are listed below: advia chemistry ldlp: for in vitro diagnostic use in the quantitative determination of lactate dehydrogenase activity in human serum and plasma on advia chemistry systems. such measurements are used mainly in the diagnosis and treatment of myocardial and pulmonary infarction. advia chemistry ldpl: for in vitro diagnostic use in the quantitative determination of lactate dehydrogenase activity in human serum and plasma on advia chemistry systems. such measurements are used mainly in the diagnosis and treatment of myocardial and pulmonary infarction.

Device

ADVIA 1200 CHEMISTRY SYSTEM - LACTATE DEHYDROGENASE L-P (LDLP) ASSAY
  • Model / Serial
    Model Catalog: 07502115 (Lot serial: ALL); Model Catalog: 03029628 (Lot serial: ALL); Model Catalog: 03030863 (Lot serial: ALL); Model Catalog: 07502999 (Lot serial: ALL)
  • Product Description
    ADVIA 1200 CHEMISTRY SYSTEM - LACTATE DEHYDROGENASE L-P (LDLP) ASSAY;ADVIA 1200 CHEMISTRY SYSTEM - LACTATE DEHYDROGENASE P-L (LDPL) ASSAY;ADVIA CHEMISTRY SYSTEM - LACTATE DEHYDROGENASE P-L (LDPL) ASSAY;ADVIA CHEMISTRY SYSTEM - LACTATE DEHYDROGENASE L-P (L
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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