Medical device recalls Moderate risk

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

Recall date
November 23, 2013
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0948-2015
FDA classification
Class II
Brand / firm
Abbott Molecular
Sold / distributed
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…

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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