Recall Z-0463-2015 ยท JJH Clinical Sample Concentrator
Abbott Molecular
Abbott m2000sp, an automated system for performing sample preparation for nucleic acid testing.
| Date | Nov 25, 2014 (initiated Oct 23, 2014) |
| Status | Terminated |
| 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. |
| Root cause | Software design (manufacturing process) |
| 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 |
| Quantity | 9 CD ROMs (US); 1,273 CD ROMs (Foreign) |
| Distribution | 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 , I |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K092705 | ABBOTT M2000SP AND ABBOTT M2000RT, MODELS 9K14-01 (G-SERIES), 9K14-02 (E-SERIES), 9K1501 Abbott Molecular, Inc., May 28, 2010 |