Home / Recalls / Medical Devices
Abbott Molecular recalls Abbott m2000sp, an automated system for performing sample preparation for nucleic acid testing.
Recalled December 3, 2014 · FDA recall Z-0463-2015 · Abbott Molecular
Hazard
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. · FDA Class II
Units
9 CD ROMs (US); 1,273 CD ROMs (Foreign)
Sold at
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
Description
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.
Product
Abbott m2000sp, an automated system for performing sample preparation for nucleic acid testing.
Manufacturer(s)
Abbott Molecular
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →