Events

Recall of exTEM Assay for the 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
    75265
  • Event Risk Class
    Class 2
  • Event Number
    Z-0302-2017
  • Event Initiated Date
    2016-09-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-12-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=149847
  • 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
    System, multipurpose for in vitro coagulation studies - Product Code JPA
  • Reason
    Customers complained of low/empty reagent vials.
  • Action
    Customers were notified of the recall by an Urgent Important Customer Information letter on 9/13/2016. The letter described the device and the problem. Customers were told to stop using the product and to call for replacement product. The letter included a Confirmation of Compliance Letter which was to be completed and returned.

Device

exTEM Assay for the ROTEM delta Thromboelastometry System
  • Model / Serial
    Lot No. 21929007
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution -- AR, CA, DC, GA, HI, ID, IL, IN, LA, ME, MD, MA, MI, MN, MO, NE, NJ, NM, NY, NC, OH, OR, PA, SC, SD, TN, TX, UT, VA, WA, and WV.
  • Product Description
    ex-TEM Assay for ROTEM delta Thromboelastometry System. Art. no.: 503-05 US, ex-tem. || Used to monitor the coagulation process via the extrinsic pathway in citrated whole blood specimens on the ROTEM delta.
  • 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