Recall Z-0948-2015— Abbott Molecular

Name: FDA recall Z-0948-2015
Creator: U.S. Food and Drug Administration
Published: 2013-11-23

Class II · Terminated

Class II FDA medical device recall by Abbott Molecular, initiated 2013-11-23, terminated 2017-12-04. It names one FDA 510(k) clearance: K092705. Product: The Abbott m2000sp is an automated system for performing sample preparation for nucleic acid testing.. Reason: The x-drive assembly may fail prematurely. This could cause the manipulator or liquid handling arm to contact an object, shake and drip, or improperly pipet..

Recalling firm: Abbott Molecular
Classification: Class II
Status: Terminated
Initiated: 2013-11-23
Terminated: 2017-12-04
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

The Abbott m2000sp is an automated system for performing sample preparation for nucleic acid testing.

Reason for recall

The x-drive assembly may fail prematurely. This could cause the manipulator or liquid handling arm to contact an object, shake and drip, or improperly pipet.

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