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Recall Observatory FDA recall evidence

Device product

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

Z-0463-2015

October 23, 2014

Class II

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

    reason.device_software_design · v1.0.0

    software version 6.0 and 7.0. This issue will cause Error