FDA Device

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

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.

What You Should Do

Remedy

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.

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Products

Abbott m2000sp, an automated system for performing sample preparation for nucleic acid testing.
Brand
Abbott Molecular
UPC
List Number: 09K14; Models: E series, G series

Units Affected

9 CD ROMs (US); 1,273 CD ROMs (Foreign)

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