Recall Z-0634-2013 ยท JJH Clinical Sample Concentrator
Abbott Molecular
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 n
| Date | Jan 3, 2013 (initiated Dec 4, 2012) |
| Status | Terminated |
| 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. |
| Root 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 |
| Quantity | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K092705 | ABBOTT M2000SP AND ABBOTT M2000RT, MODELS 9K14-01 (G-SERIES), 9K14-02 (E-SERIES), 9K1501 Abbott Molecular, Inc., May 28, 2010 |