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Recall Observatory FDA recall evidence

Device product

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

Z-0948-2015

November 23, 2013

Class II

Product summary

Firm
Abbott Molecular
Event
Event 69300
Status
Terminated
Classification
Class II
Quantity
176 devices
Official record key
device-enforcement:Z-0948-2015

Official wording

Reason: 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.

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.