Events

Recall of Device Recall MicroScan Synergies plus Panels &38; MicroScan Rapids plus (Negative)

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
    66058
  • Event Risk Class
    Class 1
  • Event Number
    Z-2125-2013
  • Event Initiated Date
    2013-08-21
  • Event Date Posted
    2013-09-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-05-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=121416
  • 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, test, automated, antimicrobial susceptibility, short incubation - Product Code LON
  • Reason
    Confirmed increase in false susceptible and false intermediate misreads for imipenem and/or meropenum on synergies plus negative and rap id/s plus negative panels read on walk away system.
  • Action
    Siemens sent an Urgent Field Safety Notice letters dated August 2013 to all US customers via over night delivery, receipt requested. Letters for foreign customers are being translated and will be sent as soon as possible. The letter identified the affected product, reason for field correction, risk to health problem and actions to be taken by customer. Customers were instructed to suppress all reporting of sensitive and intermediate results for imipenem and meropenem. Siemens also recommends that the customer consider the need to review previous test results, conduct patient follow-up, and/or repeat testing. Customer were requested to complete the attached Field Correction Effectiveness Check form and fax it to 302-631-8467. For questions contact your Siemens Technical Support Provider or Distributor.

Device

Device Recall MicroScan Synergies plus Panels &38; MicroScan Rapids plus (Negative)
  • Model / Serial
    Internal Number - B1016-202; Catalog Number - 10444601
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA Nationwide in the states of: AK, SC, IA, MO GA, WI, TX, KS, CA, IL, CO, AZ, SD, IN, MD, FL, MN and the countries of:Japan, France, Algeria, Germany, Austria, Romania, Russian Federation, South Africa, Kazakhstan, Belgium, Great Britain, Turkey, Spain, Italy, Saudi Arabia, Qutar, Poland, Iraq, Unite Arab Emrites, Algeria, Oman, Greece, Portugal, and Ireland.
  • Product Description
    Microscan plus Negative Urine Combo 4 || Sold outside of US only. || Product Usage: || MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification for gram-negative bacteria.
  • Manufacturer
    Siemens Healthcare Diagnostics, Inc.

Manufacturer

Siemens Healthcare Diagnostics, Inc.
  • Manufacturer Address
    Siemens Healthcare Diagnostics, Inc., 2040 Enterprise Blvd, West Sacramento CA 95691-3427
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    USFDA