CLASS II Device recall · Reported 3 Dec 2014 · FDA Enforcement Report

Abbott m2000sp, an automated system recalled by Abbott Molecular

Abbott Molecular is recalling Abbott m2000sp, an automated system for performing sample preparation for nucleic acid, distributed nationwide in the US. The recall was initiated on 23 Oct 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesList Number: 09K14; Models: E series, G series

Quantity recalled9 CD ROMs (US); 1,273 CD ROMs (Foreign)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0463-2015
FDA event ID: 69542
Recalling firm: Abbott Molecular, Des Plaines, IL
Classification: Class II
Status: Terminated
Recall initiated: 23 Oct 2014
FDA classified: 25 Nov 2014
Reported: 3 Dec 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

23 Oct 2014	Recall initiated by company
25 Nov 2014	Classified by FDA	+33 days
3 Dec 2014	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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

Where it was distributed

Worldwide distribution. US nationwide (CA, CT, FL, NC, PA, SC, and DC), Algeria , Australia , Austria , Belgium , Bosnia and Herzegovina , Cameroon , Canada , Chad , Colombia , Costa Rica , Croatia , Denmark , Egypt , Ethiopia , Finland , France , Germany , Greece , Guinea , Honduras , Hong Kong , India , Indonesia , Ireland , Israel , Italy , Japan , Kenya , Korea , Lithuania , Mali , Mexico , Netherlands , New Zealand , Nigeria , Norway , Pakistan , Paraguay , Poland , Portugal , Romania , Russia , Saudi Arabia , Senegal , Slovenia , South Africa , Spain , Sweden , Switzerland , Taiwan , Tanzania , Thailand , Turkey , Uganda , Ukraine , United Arab Emirates, United Kingdom , Vietnam

Nationwide California Connecticut District of Columbia Florida North Carolina Pennsylvania South Carolina

Questions about this recall

Is Abbott m2000sp, an automated system for performing sample preparation for nucleic acid recalled?

Yes. Abbott Molecular recalled Abbott m2000sp, an automated system for performing sample preparation for nucleic acid on 23 Oct 2014. The recall is Class II and its status is Terminated. Recall number Z-0463-2015.

Why was it recalled?

Which lots are affected?

List Number: 09K14; Models: E series, G series

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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