Events

Recall of Device Recall IMMULITE 2000/IMMULITE 2000 XPi CKMB

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Siemens Healthcare Diagnostics.

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
    61029
  • Event Risk Class
    Class 2
  • Event Number
    Z-1273-2012
  • Event Initiated Date
    2012-01-25
  • Event Date Posted
    2012-03-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107154
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Fluorometer method, cpk or isoenzymes - Product Code JHX
  • Reason
    Siemens healthcare diagnostics has observed that the median for the reference range with current kit lots of the ck-mb assay differs from the guidelines published in the instructions for use (ifu). this difference applies to all immulite platforms.
  • Action
    Siemens sent an "URGENT DEVICE RECALL" letter dated January 2012 to all affected customers. The letter identifies the product , problem, and actions to be taken by the customers. Siemens recommends that customers reestablish their own medians and reference ranges, in line with the recommendations made in the IFU for these products. A Field Correction Effectiveness Check form was included for customers to complete and return to the firm. Customers with questions or who need additional information should contact their Siemens Technical Solutions Center.

Device

Device Recall IMMULITE 2000/IMMULITE 2000 XPi CKMB
  • Model / Serial
    kit lot 213, 214, 215
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution.
  • Product Description
    IMMULITE¿ 2000/IMMULITE¿ 2000 XPi CK-MB L2KMB --- Catalog number: L2KMB2 (200 tests), L2KMB6 (600 tests) --- Test code: CMB Color: Dark Blue. || For in vitro diagnostic use with the IMMULITE 2000 Analyzers --- for the quantitative measurement of creatine kinase isoenzyme MB (CK-MB) in heparinized plasma or serum, as an aid in patient management and the assessment of prognosis of myocardial infarction.
  • Manufacturer
    Siemens Healthcare Diagnostics

Manufacturer

Siemens Healthcare Diagnostics
  • Manufacturer Address
    Siemens Healthcare Diagnostics, 511 Benedict Ave, Tarrytown NY 10591-5005
  • Source
    USFDA