Events

Recall of Device Recall Syva EMIT II Plus 6Acetylmorphine (Application Sheet for the Dimension EXLTM 200,

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
    79699
  • Event Risk Class
    Class 3
  • Event Number
    Z-1799-2018
  • Event Initiated Date
    2018-03-12
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=163063
  • 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
    Enzyme immunoassay, opiates - Product Code DJG
  • Reason
    Incorrect calibrator level listed in qualitative calibration steps.
  • Action
    Siemens issued an Urgent Medical Device Correction (UMDC) in the U.S. and an Urgent Field Safety Notification (UFSN) in the OUS on 13-March-2018 to notify Syva¿ Emit¿ II Plus 6-Acetylmorphine customers that the calibrator on the Application Sheet is incorrect.

Device

Device Recall Syva EMIT II Plus 6Acetylmorphine (Application Sheet for the Dimension EXLTM 200,

Manufacturer

Siemens Healthcare Diagnostics, Inc.
  • Manufacturer Address
    Siemens Healthcare Diagnostics, Inc., 511 Benedict Ave, Tarrytown NY 10591-5005
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    USFDA