Company: Abbott Molecular
Date of Enforcement Report 1/9/2013
Class ll:
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. Recall Number Z-0634-2013
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.
RECALLING FIRM/MANUFACTURER
Abbott Molecular,Des Plaines, IL 12/4/2012. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
215 units – U.S., 693 units – ROW
DISTRIBUTION
Nationwide and Internationally
___________________________________
