Abbott Molecular: Medical Device Recall in 2014 - (Recall #: Z-0463-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: October 23, 2014

Date Posted: December 3, 2014

Recall Number: Z-0463-2015

Event ID: 69542

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.

Status: Terminated

Product Quantity: 9 CD ROMs (US); 1,273 CD ROMs (Foreign)

Code Information:

List Number: 09K14; Models: E series, G series

Distribution Pattern:

Worldwide distribution. US nationwide (CA, CT, FL, NC, PA, SC, and DC), Algeria , Australia , Austria , Belgium , Bosnia and Herzegovina , Cameroon , Canada , Chad , Colombia , Costa Rica , Croatia , Denmark , Egypt , Ethiopia , Finland , France , Germany , Greece , Guinea , Honduras , Hong Kong , India , Indonesia , Ireland , Israel , Italy , Japan , Kenya , Korea , Lithuania , Mali , Mexico , Netherlands , New Zealand , Nigeria , Norway , Pakistan , Paraguay , Poland , Portugal , Romania , Russia , Saudi Arabia , Senegal , Slovenia , South Africa , Spain , Sweden , Switzerland , Taiwan , Tanzania , Thailand , Turkey , Uganda , Ukraine , United Arab Emirates, United Kingdom , Vietnam

Voluntary or Mandated:

Voluntary: Firm initiated