Z-0463-2015Class II

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

Name: Z-0463-2015 Abbott m2000sp, an automated system for performing sample preparation for nucleic acid testing
Creator: Abbott Molecular
Published: 2014-10-23
License: https://open.fda.gov/license/

Abbott Molecular, Inc. / initiated 2014-10-23 / Terminated / root cause: software

FDA source

Abbott Molecular began a recall of Abbott m2000sp, an automated system for performing sample preparation for nucleic acid testing on 2014-10-23. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0463-2015
Classification: Class II
Status: Terminated
Initiated: 2014-10-23
Posted: 2014-11-25
Terminated: 2016-03-08
Recalling firm: Abbott Molecular, Inc.
Product: Abbott m2000sp, an automated system for performing sample preparation for nucleic acid testing.
Product code: JJH Clinical Sample Concentrator
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.
Root cause tag: software
FDA 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 the local Abbott Molecular representative.
Quantity in commerce: 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 , 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
Product codes and lots: List Number: 09K14; Models: E series, G series

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0463-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0463-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-03	2014-11-25

Product code JJH

K092705Class IIAbbott M2000sp and Abbott M2000rt, Models 9K14-01 (G-Series), 9K14-02 (E-Series), 9K1501Abbott Molecular, Inc. / cleared 2010-05-28

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)