Events

Recall of Device Recall Abbott Molecular

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
    69300
  • Event Risk Class
    Class 2
  • Event Number
    Z-0948-2015
  • Event Initiated Date
    2013-11-23
  • Event Date Posted
    2015-01-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-12-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=130190
  • 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
    The x-drive assembly may fail prematurely. this could cause the manipulator or liquid handling arm to contact an object, shake and drip, or improperly pipet.
  • Action
    Abbott Molecular sent a different Field Correction Recall / Urgent Field Safety Notice letters dated October 24, 2014 to each of three sets of customers. Customers whose instruments' X-Drive Assembly belts were perviously inspected by a Field Service Representative and found to not require replacement were advised to contact their local Abbott Molecular Representative or Abbott Molecular Technical Support at 800-553-7042 x 2 should they hear any unusual noises associated with the LiHa or RoMa movement or misalignment of the LiHa or RoMa. Customers whose instruments' X-Drive Assembly belts were previously inspected and replaced by a Field Service Representative were notifieied that this maintenance activity took place. Customers with questions were instructed to contact Abbott Molelcular. For questions regarding this recall call 224-361-7000. Customers whose instruments' X-Drive Assembly belts have not been inspected were notified that a Field Service Representative is scheduled to visit their facility to inspect and if necessary, replace the X-Drive Assembly belt(s). Customers were advised to contact their local Abbott Molecular Representative should they hear any unusual noises associated with the LiHa or RoMa movement or misalignment of the LiHa or RoMa.

Device

Device Recall Abbott Molecular
  • Model / Serial
    List Number: 09K14-02; Model: E-series; Serial Numbers: 10664 - 10833, 1004, 1005, 10142, 10154, 10171, 10416
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA including CA, FL, GA, IL, MI, NC, NJ, NY, OH, OK, OR, and TX and Internationally to Australia, Austria, Belgium, Bosnia And Herzegovina, Brazil, Canada, China, Colombia, Costa Rica, Denmark, Dominican Republic, Egypt, Finland, France, Germany, Indonesia, Ireland, Israel, Italy, Kazakhstan, Kenya, Malawi, Mali, Mexico, Morocco, Mozambique, New Zealand, Nigeria, Norway, Pakistan, Poland, Russia, Saudi Arabia, Senegal, South Africa, South Korea, Taiwan, Thailand, Turkey, Ukraine, and United Kingdom.
  • Product Description
    The Abbott m2000sp is 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