Events

Recall of Device Recall Dimension Enzyme II calibrator

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Siemens Healthcare Diagnostics, 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
    76293
  • Event Risk Class
    Class 3
  • Event Number
    Z-1217-2017
  • Event Initiated Date
    2016-05-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-02-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=152701
  • 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
    Calibrator, secondary - Product Code JIT
  • Reason
    Complaints of positive shift of patient and qc results when the alti assay is calibrated with the dimension enzyme ii calibrator. internal investigation has confirmed that patient samples and qc material demonstrate a shift of up to 10% in comparison to results obtained using earlier calibrator lots.
  • Action
    Siemens mailed an Urgent Medical Device Notification letter to all affected customers on May 10, 2016. The notice provided information on actions to be taken by the customer to work around the issue. For further questions, please call (800) 441-9250.

Device

Device Recall Dimension Enzyme II calibrator
  • Model / Serial
    Product Lot: 4MD047, 5CD052, 5FD017, 5GD050, 5HD010, 5JD069, 5LD051, 6AD054
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed throughout the United States
  • Product Description
    The Enzyme II Calibrator is an in vitro diagnostic product for the Alanine Aminotransferase (ALTI) on the Dimension¿ clinical chemistry system. For prescription use only.
  • Manufacturer
    Siemens Healthcare Diagnostics, Inc.

Manufacturer

Siemens Healthcare Diagnostics, Inc.
  • Manufacturer Address
    Siemens Healthcare Diagnostics, Inc., 500 Gbc Dr Ms 514, PO BOX 6101, Newark DE 19702-2466
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    USFDA