Class 2 Device Recall Abbott Molecular

• Date Initiated by Firm: November 23, 2013
• Date Posted: January 09, 2015
• Recall Status: Terminated on December 04, 2017
• Recall Number: Z-0948-2015
• Recall Event ID: 69300
• 510(K)Number: K092705
• Product Classification: Clinical sample concentrator - Product Code JJH
• Product: The Abbott m2000sp is an automated system for performing sample preparation for nucleic acid testing.
• Code Information: List Number: 09K14-02; Model: E-series; Serial Numbers: 10664 - 10833, 1004, 1005, 10142, 10154, 10171, 10416
• Recalling Firm/ Manufacturer: Abbott Molecular; 1300 E Touhy Ave; Des Plaines IL 60018-3315
• For Additional Information Contact: 224-361-7000
• Manufacturer Reason for Recall: 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.
• FDA Determined Cause: Nonconforming Material/Component
• 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.
• Quantity in Commerce: 176 devices
• 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = JJH and Original Applicant = ABBOTT MOLECULAR, INC.