Events

Recall of Device Recall Syva Emit Methotrexate Assay

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
    73594
  • Event Risk Class
    Class 2
  • Event Number
    Z-1618-2016
  • Event Initiated Date
    2016-03-08
  • Event Date Posted
    2016-05-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-08-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144546
  • 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, methotrexate - Product Code LAO
  • Reason
    Siemens healthcare diagnostics confirmed that syva emit methotrexate application (dvmtx.1) for dimension vista system does not meet on-board stability claim of 20 hours. testing using reagent at the end of the 20 hours on-board stability has shown that values of methotrexate for patient and quality control samples increased.
  • Action
    Siemens mailed an Urgent Medical Device Correction letter to customers informing them that they were withdrawing the Emit Methotrexate Application on the Dimension Vista System. Customers were asked to contact their local Siemens sales representative for alternative testing solutions for Methotrexate. Siemens advised customers to change the On-Board Stability for the Methotrexate application on the Dimension Vista System to four hours: alternatively, customers can run the Methotrexate application in batch mode, along with QC. It was also requested in the notification that customers complete and return the Field Correction Effectiveness Check Form that was attached with the notification within 30 days.

Device

Device Recall Syva Emit Methotrexate Assay
  • Model / Serial
    Lot # F1, F2, G1, G2, H1, and H2
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    Unclassified
  • Implanted device?
    No
  • Distribution
    Units were shipped to MI, FL, NJ, NY, DC, CA, GA, MI, MT, VA, NC, TX, PA, Australia, Belgium, Czech Republic, Finland, Japan, Republic of Korea, Italy, Saudi Arabia, Slovakia, Slovenia, Spain and Switzerland.
  • Product Description
    Syva Emit Methotrexate Assay, is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of methotrexate in human serum or plasma.
  • 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