Z-0948-2015Class II

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

Name: Z-0948-2015 The Abbott m2000sp is an automated system for performing sample preparation for nucleic acid testing
Creator: Abbott Molecular
Published: 2013-11-23
License: https://open.fda.gov/license/

Abbott Molecular, Inc. / initiated 2013-11-23 / Terminated / root cause: manufacturing process

FDA source

Abbott Molecular began a recall of The Abbott m2000sp is an automated system for performing sample preparation for nucleic acid testing on 2013-11-23. FDA classified it as Class II and gives the reason as "The x-drive assembly may fail prematurely. This could cause the manipulator or liquid handling arm to contact an object, shake and drip, or improperly pipet". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0948-2015
Classification: Class II
Status: Terminated
Initiated: 2013-11-23
Posted: 2015-01-09
Terminated: 2017-12-04
Recalling firm: Abbott Molecular, Inc.
Product: The Abbott m2000sp is an automated system for performing sample preparation for nucleic acid testing.
Product code: JJH Clinical Sample Concentrator
Reason for recall: The x-drive assembly may fail prematurely. This could cause the manipulator or liquid handling arm to contact an object, shake and drip, or improperly pipet.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Abbott Molecular sent a different Field Correction Recall / Urgent Field Safety Notice letters dated October 24, 2014 to each of three sets of customers. Customers whose instruments' X-Drive Assembly belts were perviously inspected by a Field Service Representative and found to not require replacement were advised to contact their local Abbott Molecular Representative or Abbott Molecular Technical Support at 800-553-7042 x 2 should they hear any unusual noises associated with the LiHa or RoMa movement or misalignment of the LiHa or RoMa. Customers whose instruments' X-Drive Assembly belts were previously inspected and replaced by a Field Service Representative were notifieied that this maintenance activity took place. Customers with questions were instructed to contact Abbott Molelcular. For questions regarding this recall call 224-361-7000. Customers whose instruments' X-Drive Assembly belts have not been inspected were notified that a Field Service Representative is scheduled to visit their facility to inspect and if necessary, replace the X-Drive Assembly belt(s). Customers were advised to contact their local Abbott Molecular Representative should they hear any unusual noises associated with the LiHa or RoMa movement or misalignment of the LiHa or RoMa.
Quantity in commerce: 176 devices
Distribution: Worldwide Distribution - USA including CA, FL, GA, IL, MI, NC, NJ, NY, OH, OK, OR, and TX and Internationally to Australia, Austria, Belgium, Bosnia And Herzegovina, Brazil, Canada, China, Colombia, Costa Rica, Denmark, Dominican Republic, Egypt, Finland, France, Germany, Indonesia, Ireland, Israel, Italy, Kazakhstan, Kenya, Malawi, Mali, Mexico, Morocco, Mozambique, New Zealand, Nigeria, Norway, Pakistan, Poland, Russia, Saudi Arabia, Senegal, South Africa, South Korea, Taiwan, Thailand, Turkey, Ukraine, and United Kingdom.
Product codes and lots: List Number: 09K14-02; Model: E-series; Serial Numbers: 10664 - 10833, 1004, 1005, 10142, 10154, 10171, 10416

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0948-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0948-2015	Class II	Terminated	Voluntary: Firm initiated	2015-01-21	2015-01-09

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)