Events

Recall of Device Recall MicroScan Neg Breakpoint Combo 34

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
    70874
  • Event Risk Class
    Class 2
  • Event Number
    Z-1522-2015
  • Event Initiated Date
    2014-05-14
  • Event Date Posted
    2015-04-26
  • 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=135379
  • 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
    Siemens healthcare diagnostics has received complaints regarding panel degradation with a portion of the microscan neg breakpoint combo 34 (nbp34) panel lot 2014-05-28.
  • Action
    Siemens sent an Urgent Medical Device Recall letter dated May 14, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The risk to health is explained and users are asked to discontinue use and discard any of the recalled lot still in inventory. No other lot numbers of the NBPC 34 panels are affected and may still be used. The Field Correction Effectiveness Check form should have been completed and returned to Siemens. PLEASE FAX THIS COMPLETED FORM TO 302-631-8467. Contact Siemens Customer Care Center or local Siemens Tech support. For further questions please call (916) 374-3031

Device

Device Recall MicroScan Neg Breakpoint Combo 34
  • Model / Serial
    Catalog Number B1017-404, lot # 2014-05-28, Expiry 2014-05-28.
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - Nationwide Distribution including Puerto Rico and to the states of: KS, LA, MD, NY, WV,NM, NH, MO, CT, MA, OK, NC. IA, OH. WI, TX, PA, MS and MN and to the countries of : Canada, Kuwait, South Africa and Turkey.
  • Product Description
    MicroScan -Neg Breakpoint Combo Panel Type 34; || Catalog number B1017-404; Panel || MicroScan Neg Breakpoint 34 Neg panels are designed for use in determining quantitative and /or qualitative antimicrobial agent susceptibility and /or identification to || No.1 the species level of colonies, grown 34 on solid media, of rapidly growing || aerobic and facultative anaerobic gram-positive bacteria
  • 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