Class 2 Device Recall Abbott m2000sp Instrument

• Date Initiated by Firm: December 04, 2012
• Date Posted: January 03, 2013
• Recall Status: Terminated on March 08, 2016
• Recall Number: Z-0634-2013
• Recall Event ID: 63746
• 510(K)Number: K092705
• Product Classification: Clinical sample concentrator - Product Code JJH
• Product: 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.
• Code Information: list 09K14, all serial numbers and all software versions 1.0 - 5.0
• Recalling Firm/ Manufacturer: Abbott Molecular; 1300 E Touhy Ave; Des Plaines IL 60018-3315
• For Additional Information Contact: Ms. Jean Leete; 224-361-7274
• Manufacturer Reason for Recall: 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.
• FDA Determined Cause: Software design
• 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.
• Quantity in Commerce: 215 units - U.S., 693 units - ROW
• 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
• 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.