Abbott m2000sp, an automated system for performing sample preparation for nucleic acid testing.
FDA device recall Z-0463-2015 · posted 2014-11-25 · Terminated
Recall details
- Recalling firm
- Abbott Molecular
- 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.
- Action taken
- 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)
- Status
- Terminated
- Product code
- JJH
- Quantity affected
- 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 ,
- Date initiated
- 2014-10-23
- Date posted
- 2014-11-25
- Date terminated
- 2016-03-08
- Location
- Des Plaines, IL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ABBOTT M2000SP AND ABBOTT M2000RT, MODELS 9K14-01 (G-SERIES), 9K14-02 (E-SERIES), 9K1501 (K092705) | Abbott Molecular, Inc. | 2010-05-28 |