Device product
Abbott m2000sp, an automated system for performing sample preparation for nucleic acid testing.
Z-0463-2015
Product summary
- Firm
- Abbott Molecular
- Event
- Event 69542
- Status
- Terminated
- Classification
- Class II
- Quantity
- 9 CD ROMs (US); 1,273 CD ROMs (Foreign)
- Official record key
device-enforcement:Z-0463-2015
Official wording
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.
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
Derived failure modes
-
Device software or design
software version 6.0 and 7.0. This issue will cause Error