Abbott Molecular: Medical Device Recall in 2015 - (Recall #: Z-0948-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: November 23, 2013

Date Posted: January 21, 2015

Recall Number: Z-0948-2015

Event ID: 69300

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.

Status: Terminated

Product Quantity: 176 devices

Code Information:

List Number: 09K14-02; Model: E-series; Serial Numbers: 10664 - 10833, 1004, 1005, 10142, 10154, 10171, 10416

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated