FDA-Device2014-12-03Class II
Abbott m2000sp, an automated system for performing sample preparation for nucleic acid testing.
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.
Sold states
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
Affected count
9 CD ROMs (US); 1,273 CD ROMs (Foreign)
Manufactured in
1300 E Touhy Ave, N/A, Des Plaines, IL, United States
Products
Abbott m2000sp, an automated system for performing sample preparation for nucleic acid testing.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0463-2015Don't want to check this manually?
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