Events

Recall of Device Recall Abbott m2000sp Instrument

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
    63746
  • Event Risk Class
    Class 2
  • Event Number
    Z-0634-2013
  • Event Initiated Date
    2012-12-04
  • Event Date Posted
    2013-01-03
  • 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=114697
  • 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
    An issue with the m2000sp instrument software has been identified whereby, after a series of steps, if changes are made to the control or calibrator information on the sample extraction assay details screen, the changes are not saved.
  • Action
    Abbott Molecular Inc. sent a Field Correction Recall/Urgent Field Safety Notice letter dated December 4, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The customer was instructed to follow the instructions identified until an upgrade to their m2000sp software can be installed. Abbott Molecular estimates that this software version will be available the first quarter of 2013. They were requested to complete the enclosed reply sheet and fax it to (847) 775-6728 at prior to December 18, 2012 to acknowledge receipt and understanding of the letter. For questions customers were instructed to contact their local Abbott Molecular representative. For questions regarding this recall call 224-361-7274.

Device

Device Recall Abbott m2000sp Instrument
  • Model / Serial
    list 09K14, all serial numbers and all software versions 1.0 - 5.0
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and internationally to Algeria, Argentina, Australia, Austria, Azerbaijan, Belgium, Bolivia, Brazil, Burkina Faso, Burundi, Cameroon, Canada, Chad, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Ethiopia, Estonia, Finland, France, Gaza & Jericho, Germany, Greece, Guinea, Haiti, Honduras, Hong Kong, India, Indonesia, Ireland, Israel, Italy, Japan, Kazakhstan, Kenya, Libya, Lithuania, Luxembourg, Malawi, Malaysia, Mali, Mexico, Mozambique, Netherlands, New Zealand, Norway, Pakistan, Panama, Paraguay, Peru, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Venezuela, Vietnam and Zambia
  • Product Description
    Abbott m2000sp Instrument; an automated fluid handling system for performing sample preparation for nucleic acid testing; Abbott Molecular Inc., Des Plaines, IL 60018 USA; Abbott m2000sp Instrument; an automated system for performing sample preparation for nucleic acid testing; Abbott Molecular Inc., Des Plaines, IL 60018 USA; list 09K14 || The Abbott m2000 System is intended for use in performing nucleic acid testing in clinical laboratories.
  • Manufacturer
    Abbott Molecular

Manufacturer

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