Recall Z-0634-2013— Abbott Molecular

Name: FDA recall Z-0634-2013
Creator: U.S. Food and Drug Administration
Published: 2012-12-04

Class II · Terminated

Class II FDA medical device recall by Abbott Molecular, initiated 2012-12-04, terminated 2016-03-08. It names one FDA 510(k) clearance: K092705. 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.. 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: Abbott Molecular
Classification: Class II
Status: Terminated
Initiated: 2012-12-04
Terminated: 2016-03-08
Firm location: Des Plaines, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K092705 — ABBOTT M2000SP AND ABBOTT M2000RT, MODELS 9K14-01 (G-SERIES), 9K14-02 (E-SERIES), 9K1501Abbott Molecular, Inc.·cleared 2010-05-28

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.