Events

Recall of Microscan Neg Combo 50, B1017406

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Beckman Coulter, 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
    70893
  • Event Risk Class
    Class 2
  • Event Number
    Z-1528-2015
  • Event Initiated Date
    2014-08-08
  • Event Date Posted
    2015-04-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-04-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=135419
  • 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
    Manual antimicrobial susceptibility test systems - Product Code JWY
  • Reason
    Technical support bulletin issued in february 2013 did not mention performance limitation for proteus mirabilis and imp when using the clsim100-s20 revised interpretive criteria.
  • Action
    The firm, Siemens, sent an "Urgent Medical Device Correction" letter dated August 7, 2014 to affected customers by trackable method. The letter describe product, problem and actions to be taken. The customers were instructed to confirm receipt of the letter; complete the attached "Field Correction Effectiveness Check" form via fax to Siemens Healthcare Diagnostics at 302-631-8467;TSB 190 has been removed from use and archived from the Siemens Document Library, if you have a hardcopy, discard it appropriately;and follow the listed in instructions and retain and forward this letter to those who may have received this product. If you have any questions, please contact your Siemens Customer Care Center; Quality Systems & Compliance Director at 916-374-3031 or email: juntalan@beckman.com or your local Siemens technical support representative.

Device

Microscan Neg Combo 50, B1017406
  • Model / Serial
    Catalog number: B1017-406; Siemens Material Number (SMN): 10444700.
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: US (Nationwide) and to countries of: Argentina, Bahamas, Brazil, Canada, China, Ecuador, Egypt, Germany, Lithuania, Mexico, Paraguay, Peru Poland, Portugal, Romania, Russian Federation, Singapore, South Africa, Spain, Taiwan, Thailand, Trinidad and Tobago, United Arab Emirates, Uruguay, and Venezuela.
  • Product Description
    MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels || Containing Lower Imipenem Dilutions for Reporting CLSI M100-S20 || Breakpoints || Panel: Neg Combo 50, Catalog B1017-406 || Microbiology: For use with MicroScan Dried Gram Negative MIC/Combo Panels and Dried Gram Negative Breakpoint Combo Panels. MicroScan panels are designed || for use in determining antimicrobial agent susceptibility and/or identification to the || species level of aerobic and facultatively anaerobic gram-negative bacilli.
  • Manufacturer
    Beckman Coulter, Inc.

Manufacturer

Beckman Coulter, Inc.
  • Manufacturer Address
    Beckman Coulter, Inc., 2040 Enterprise Blvd, West Sacramento CA 95691-3427
  • Manufacturer Parent Company (2017)
    Danaher Corporation
  • Source
    USFDA