Events

Recall of Device Recall ROTROL P Contorl for ROTEM delta Thromboelastometry System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by TEM Systems 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
    73357
  • Event Risk Class
    Class 2
  • Event Number
    Z-1090-2016
  • Event Initiated Date
    2016-02-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-06-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143943
  • 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
    Plasma, coagulation control - Product Code GGN
  • Reason
    Customer complaints about failed target ranges for alpha angle. firm has not completed the capa identifying the root cause. projected completion of the capa by the firm is july 2016.
  • Action
    An Urgent Important Customer Information notice was sent to accounts on 2/17/2016. The notice requested that they discontinue use of the product and to contact them for a replacement. The letter also included a response form to be returned.

Device

Device Recall ROTROL P Contorl for ROTEM delta Thromboelastometry System
  • Model / Serial
    Lot 41925401
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed in the states of AZ, AR, CA, FL, GA, HI, ID, IL, IN, LA, MD, MA, MN, MO, NE, NJ, NM, NY, PA, OH, SC, SD, TN, TX, UT, WA, WV and the country of Germany.
  • Product Description
    ROTROL P Control for ROTEM delta Thromboelastometry System, For In Vitro Diagnostic Use Only. Quality control material for monitoring accuracy and precision of test carried out on the ROTEM delta Thromboelastometry System.
  • Manufacturer
    TEM Systems Inc

Manufacturer

TEM Systems Inc
  • Manufacturer Address
    TEM Systems Inc, 3210 E Nc Hwy 54, Durham NC 27709
  • Manufacturer Parent Company (2017)
    Tem Systems Inc.
  • Source
    USFDA