Events

Recall of Abbott Molecular Abbott m2000sp

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

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
    69542
  • Event Risk Class
    Class 2
  • Event Number
    Z-0463-2015
  • Event Initiated Date
    2014-10-23
  • Event Date Posted
    2014-11-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-03-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=130892
  • 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
    Clinical sample concentrator - Product Code JJH
  • Reason
    Some versions of application specifications (app spec) are incompatible with m2000sp system software version 6.0 and 7.0. this issue will cause error code 9000 (an unexpected error has occurred: software error) to be generated when the available reagent packs screen is selected.
  • Action
    Field Correction Recall / Urgent Field Safety Notice letters dated September 23, 2014 were sent to all direct accounts (customers). The letters included instructions for customers to: 1) review the app spec files that are installed on the m2000sp system and delete any incompatible app specs; 2) if one or more app spec files were deleted, installation of new app spec file(s) is needed; and, 3) review this information with laboratory personnel and retain the letter for future reference. Customers with questions about this market action can contact Technical Support at 800-553-7042, Option 2, or the local Abbott Molecular representative.

Device

Abbott Molecular Abbott m2000sp
  • Model / Serial
    List Number: 09K14; Models: E series, G series
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide distribution. US nationwide (CA, CT, FL, NC, PA, SC, and DC), Algeria , Australia , Austria , Belgium , Bosnia and Herzegovina , Cameroon , Canada , Chad , Colombia , Costa Rica , Croatia , Denmark , Egypt , Ethiopia , Finland , France , Germany , Greece , Guinea , Honduras , Hong Kong , India , Indonesia , Ireland , Israel , Italy , Japan , Kenya , Korea , Lithuania , Mali , Mexico , Netherlands , New Zealand , Nigeria , Norway , Pakistan , Paraguay , Poland , Portugal , Romania , Russia , Saudi Arabia , Senegal , Slovenia , South Africa , Spain , Sweden , Switzerland , Taiwan , Tanzania , Thailand , Turkey , Uganda , Ukraine , United Arab Emirates, United Kingdom , Vietnam
  • Product Description
    Abbott m2000sp, an automated system for performing sample preparation for nucleic acid testing.
  • Manufacturer
    Abbott Molecular

Manufacturer

Abbott Molecular
  • Manufacturer Address
    Abbott Molecular, 1300 E Touhy Ave, Des Plaines IL 60018-3315
  • Source
    USFDA