Events

Recall of Device Recall Hettich Centrifuge Module

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
    74280
  • Event Risk Class
    Class 2
  • Event Number
    Z-2087-2016
  • Event Initiated Date
    2016-05-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-04-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=147052
  • 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
    Equipment, laboratory, general purpose, labeled or promoted for a specific medical use - Product Code LXG
  • Reason
    Premature bucket failures.
  • Action
    Siemens mailed to customers an Urgent Medical Device Correction (UMDC#LAI16-02.A.US) Urgent Field Safety Notification letter informing customers of the problem with recommendations to follow the existing maintenance instructions in the product operator manuals as well as a new requirement to spin at cycle speeds not exceeding 3500 rpm.

Device

Device Recall Hettich Centrifuge Module
  • Model / Serial
    All serial numbers are affected.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide: AL, AR, AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, PA, SC, SD, TN, TX, VA, WA, WI, WV.
  • Product Description
    Hettich Centrifuge Modules: || StreamLAB Centrifuge Module (10372372 or 10444807 or 10706836) || Aptio Centrifuge Module (10703032 or 10713761) || FlexLab High Throughput Centrifuge Module (11171747) || FlexLab and Aptio Centrifuge Module (10628157 or 11266581): Used to separate substances according to their densities.
  • Manufacturer
    Siemens Healthcare Diagnostics Inc.

Manufacturer

Siemens Healthcare Diagnostics Inc.
  • Manufacturer Address
    Siemens Healthcare Diagnostics Inc., 101 Silvermine Rd, Brookfield CT 06804-2047
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    USFDA