Recall Z-0463-2015— Abbott Molecular

Name: FDA recall Z-0463-2015
Creator: U.S. Food and Drug Administration
Published: 2014-10-23

Class II · Terminated

Class II FDA medical device recall by Abbott Molecular, initiated 2014-10-23, terminated 2016-03-08. It names one FDA 510(k) clearance: K092705. Product: Abbott m2000sp, an automated system for performing sample preparation for nucleic acid testing.. Reason: Some versions of Application Specifications (App Spec) are incompatible with m2000sp system software version 6.0 and 7.0. This issue will cause Error Code 9000 (An unexpected error has occurred: Software error) to be generated when the Available Reagent Packs screen is selected..

Recalling firm: Abbott Molecular
Classification: Class II
Status: Terminated
Initiated: 2014-10-23
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, an automated system for performing sample preparation for nucleic acid testing.

Reason for recall

Some versions of Application Specifications (App Spec) are incompatible with m2000sp system software version 6.0 and 7.0. This issue will cause Error Code 9000 (An unexpected error has occurred: Software error) to be generated when the Available Reagent Packs screen is selected.

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