Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Abbott m2000sp Recalled by Abbott Molecular Due to Some versions of Application Specifications (App Spec) are...

Date: October 23, 2014
Company: Abbott Molecular
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Abbott Molecular directly.

Affected Products

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

Quantity: 9 CD ROMs (US); 1,273 CD ROMs (Foreign)

Why Was This 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.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Abbott Molecular

Abbott Molecular has 6 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report