Events

Recall of Device Recall MicroScan LabPro Information Manager System

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
    73417
  • Event Risk Class
    Class 2
  • Event Number
    Z-1269-2016
  • Event Initiated Date
    2016-02-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-01-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144164
  • 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
    Medical device data system - Product Code OUG
  • Reason
    Beckman coulter is recalling the microscan labpro information manager system because the software incorrectly allows the operator to manually edit the carbohydrate substrates when manually reading dried overnight gram negative panels with an id hold status.
  • Action
    An Urgent Medical Device Recall Letter dated 2/11/2016 was sent to all customers who purchased the MicroScan LabPro Information Manager System, Version 1.0 to Version 4.41. Beckman Coulter is expanding the recall that was initiated in July 2015 regarding FA-25776 for the MicroScan LabPro Information Manager System. The letter informs the customers of the problems identified and the actions to be taken. Customers are instructed to complete and return the enclosed Response Form within 10 days. Customers with questions are instructed to contact Customer Support Representative: http:www.beckmancoulter.com, (800) 677-7226 in US and Canada. Customers outside of US and Canada, are instructed to contact their local Beckman Coulter representative.

Device

Device Recall MicroScan LabPro Information Manager System
  • Model / Serial
    not applicable
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Affected geographies: Bahamas, Belgium, Brazil, Canada, Chile, China, Colombia, Czech Republic, France, French Guiana, Germany, Ghana, Greece, Guadeloupe, Guatemala, India, Israel, Italy, Japan, Kazakhstan, Lithuania, Mexico, Morocco, Netherlands, Northern Mariana Islands, Panama, Paraguay, Peru, Poland, Portugal, Puerto Rico, Romania, Russia, Singapore, South Africa, Spain, Taiwan, Tunisia, Turkey, United States, Uruguay, Virgin Islands, Zimbabwe.
  • Product Description
    MicroScan LabPro Information Manager System, Software Versions 1.0 to 4.41 || Catalog No. 10638819, 10638820, 10638823, 10638824, 10638825,10638826, 10714149,10714159, 10805072, 10805073, 10975000, 10975001, 6000-0008, 6000-0026. || Japan: || 10638819 LabPro v4.11 Software Update Kit || 10638820 LabPro v4.11 System Software || 10805072 LabPro MBT Non-Connect Systems v4.30 || 10805073 LabPro MBT Connect Systems v4.30 || Canada: || 6000-0008 LabPro v4.41 Panel Update-06 Kit || 6000-0026 LabPro Connect v4.41 Panel Update-06 Kit || 10638823 LabPro v4.11 Software Update Kit || 10638825 LabPro v4.11 System Software || 10638824 LabPro v4.11 Software Update Kit || Europe: || 10638824 LabPro v4.11 Software Update Kit || 10638826 LabPro v4.11 System Software || USA: || 10714149, LabPro v4.11 Software Update Kit || 10714150 LabPro v4.11 System Software || 10975000 ASM LabPro-MBT v4.40 || 10975001 ASM LabPro-MBT v4.40 for Connect || 6000-0008 LabPro v4.41 Panel Update-06 Kit || 6000-0026 LabPro Connect v4.41 Panel Update-06 Kit || ROW: || 6000-0008 LabPro v4.41 Panel Update-06 Kit || 10638823 LabPro v4.11 Software Update Kit || 10638825 LabPro v4.11 System Software || 10638824 LabPro v4.11 Software Update Kit || 10638826 LabPro v4.11 System Software || Product Usage: || LabPro Data Management System is a Microsoft Windows based software program and is intended to manage both microbial identification (ID) and antimicrobial agent susceptibility testing (AST) data generated from MicroScan instruments or manually entered microbiology test results, for use by trained laboratory personnel. LabPro AlertEx is a functional subset of the LabPro Data Management System that analyzes MicroScan ID and AST data, or other predefined parameters, against a series of established rules/alerts and notifies the user of unusual and/or critical conditions, which may warrant further analysis or actions.
  • Manufacturer
    Beckman Coulter Inc.

Manufacturer

Beckman Coulter Inc.
  • Manufacturer Address
    Beckman Coulter Inc., 250 S Kraemer Blvd, Brea CA 92821-6232
  • Manufacturer Parent Company (2017)
    Danaher Corporation
  • Source
    USFDA