Events

Recall of Device Recall MicroScan Dried Negative Breakpoint Combo

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
    65188
  • Event Risk Class
    Class 2
  • Event Number
    Z-1525-2013
  • Event Initiated Date
    2013-05-02
  • Event Date Posted
    2013-06-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-09-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=118168
  • 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
    Panels, test, susceptibility, antimicrobial - Product Code LTT
  • Reason
    The product has the potential for false negative or delayed reaction for arginine (arg) results. in addition, 42 hour identification panel holds may occur due to a weak arg reaction.
  • Action
    Siemens sent an Urgent Field Safety Notice dated May 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact your local Siemens Healthcare Diagnostics Representative for information concerning this notice.

Device

Device Recall MicroScan Dried Negative Breakpoint Combo
  • Model / Serial
    Lot: 2013-11-13, Exp 11/13/2013.
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution.
  • Product Description
    Siemens brand MicroScan Dried Negative Breakpoint Combo 47 panels (B1017-417), SMN #: 10483099), || For use in determining quantitative and/or qualitative antimicrobial agent susceptibility.
  • 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