Abbott m2000sp Instrument; an automated fluid handling system for performing sample preparation for nucleic acid testing

FDA device recall Z-0634-2013 · posted 2013-01-03 · Terminated

Recall details

Recalling firm

Abbott Molecular

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.

Action taken

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.

Root cause

Software design

Status

Terminated

Product code

JJH

Quantity affected

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, Chi

Date initiated

2012-12-04

Date posted

2013-01-03

Date terminated

2016-03-08

Location

Des Plaines, IL

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