Reported Dec 3, 2014 · Terminated

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

Abbott Molecular

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Abbott Molecular · 1300 E Touhy Ave · Des Plaines, IL · 60018-3315

Is this the product you have?

  • Abbott m2000sp, an automated system for performing sample preparation for nucleic acid testing.
Lot codes and dates
  • List Number09K14
  • ModelsE series, G series
Amount recalled
9 CD ROMs (US); 1,273 CD ROMs (Foreign)

Where it was sold

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Mar 8, 2016 · Data as of Sep 19, 5:21 PM UTC

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