Events

Recall of IMMULITE 2000 SYSTEM - CK-MB 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
    84898
  • Event Risk Class
    III
  • Event Initiated Date
    2012-01-27
  • 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
    The median for the reference range with current kit lots differs from the guidelines published in the instructions for use.

Device

IMMULITE 2000 SYSTEM - CK-MB ASSAY
  • Model / Serial
    Model Catalog: L2KMB6 (Lot serial: L2KMB 214); Model Catalog: L2KMB2 (Lot serial: L2KMB 214); Model Catalog: L2KMB6 (Lot serial: L2KMB 213); Model Catalog: L2KMB2 (Lot serial: L2KMB 213); Model Catalog: LKMB5 (Lot serial: LKMB 313); Model Catalog: LKMB1 (Lot serial: LKMB 313); Model Catalog: LKMB5 (Lot serial: LKMB 312); Model Catalog: LKMB1 (Lot serial: LKMB 312); Model Catalog: L5KCP6 (Lot serial: L5KCP 137); Model Catalog: L5KCP2 (Lot serial: L5KCP 137); Model Catalog: L5KCP6 (Lot serial: L5KCP 136); Model Catalog: L5KCP2 (Lot serial: L5KCP 136); Model Catalog: LSKCP5 (Lot serial: LSKCP 318); Model Catalog: LSKCP1 (Lot serial: LSKCP 318); Model Catalog: LSKCP5 (Lot serial: LSKCP 316); Model Catalog: LSKCP1 (Lot serial: LSKCP 316); Model Catalog: L2KMB6 (Lot serial: L2KMB 215); Model Catalog: L2KMB2 (Lot serial: L2KMB 215)
  • Product Description
    IMMULITE 2000 SYSTEM CK-MB ASSAY
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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