Events

Recall of Device Recall MicroScan

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Dade Behring.

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
    31125
  • Event Risk Class
    Class 1
  • Event Number
    Z-0668-05
  • Event Initiated Date
    2005-02-07
  • Event Date Posted
    2005-04-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-07-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=37195
  • 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
    There is a potential for reporting of false susceptible anti-microbic results that could result in inappropriate and/or less effective therapy.
  • Action
    The customer notifications were sent to U.S. customers on January 27, 2005 via FedEx. International customers are to be notified by Dade Behring affiliates in the affected countries by February 10, 2005. Follow up will be made via phone call.

Device

Device Recall MicroScan
  • Model / Serial
    Lot Nos.:  050905A-1,  051005A-1,  051605A-1,  051705A-1,  052305A-1,  052805B-1
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    71 consignees including customers in U.S., Puerto Rico and distributors. Number of international customers to be determined at completion of effectiveness check.
  • Product Description
    MicroScan¿ Rapid Pos Inoculum Broth, Catalog #: B1015-14; Manufactured and distributed by: Dade Behring Inc. 2040 Enterprise Blvd. West Sacramento, CA 95691
  • Manufacturer
    Dade Behring

Manufacturer

Dade Behring
  • Manufacturer Address
    Dade Behring, 2040 Enterprise Blvd, West Sacramento CA 95691-3427
  • Source
    USFDA