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Terminated

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

FDA Recall Z-0463-2015 · Posted 2014-11-25

Recalling FirmAbbott Molecular
Recall StatusTerminated
Product CodeJJH
Date Initiated2014-10-23
Date Terminated2016-03-08
Product Quantity9 CD ROMs (US); 1,273 CD ROMs (Foreign)

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.

Firm Action

Field Correction Recall / Urgent Field Safety Notice letters dated September 23, 2014 were sent to all direct accounts (customers). The letters included instructions for customers to: 1) review the app spec files that are installed on the m2000sp system and delete any incompatible app specs; 2) if one or more app spec files were deleted, installation of new app spec file(s) is needed; and, 3) review this information with laboratory personnel and retain the letter for future reference. Customers with questions about this market action can contact Technical Support at 800-553-7042, Option 2, or the local Abbott Molecular representative.

Root Cause

Software design (manufacturing process)

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K092705ABBOTT M2000SP AND ABBOTT M2000RT, MODELS 9K14-01 (G-SERIES), 9K14-02 (E-SERIES), 9K1501Abbott Molecular, Inc. · 2010-05-28

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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