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Abbott Molecular Recalls
36 recalls on record · July 25, 2012 to May 21, 2025 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
January 21, 2015Medical DevicesFDA
Abbott Molecular recalls The Abbott m2000sp is an automated system for performing sample preparation for nucleic acid testing.
Hazard: 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.
December 3, 2014Medical DevicesFDA
Abbott Molecular recalls Abbott m2000sp, an automated system for performing sample preparation for nucleic acid testing.
Hazard: 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.
August 20, 2014Medical DevicesFDA
Abbott Molecular recalls 5 mL Reaction Vessels (a consumable of the Abbott m2000sp Automated Fluid Handling System). The Abbott m2000 RealTime Sy
Hazard: Abbott Molecular identified that some of the 5 ml Reaction Vessels (RVs) contained in lots 56944001, 57026001, 57059001, and 57673001 (original vendor lot 2198077) may have an insufficient rim. An RV with an insufficient rim may not be held securely in the 1 mL Subsystem Carrier. This may cause the RV to be seated incorrectly in the carrier or drop through it.
April 30, 2014Medical DevicesFDA
Abbott Molecular recalls The CEP 8 SpectrumGreen (SG) ASR Probe Kit, 20ul (list 06J37-018) is an Analyte Specific Reagent (ASR) containing a sing
Hazard: 20 kits of CEP 8 SG ASR Probe (list 06J37-018, lot 440023), contained Vysis CEP 4 (Alpha Satellite) SG Probe, 20u, (part 32-112004 lot 438814), instead of the expected CEP 8 probe.
January 9, 2013Medical DevicesFDA
Abbott Molecular recalls Abbott m2000sp Instrument; an automated fluid handling system for performing sample preparation for nucleic acid testing
Hazard: An issue with the m2000sp Instrument software has been identified whereby, after a series of steps, if changes are made to the control or calibrator information on the Sample Extraction Assay Details screen, the changes are not saved.
July 25, 2012Medical DevicesFDA
Abbott Molecular recalls Abbott Molecular Bar Code Scanner User's Guide; instructions for setting up the Bar Code Scanner LN 6L89-01, a component
Hazard: In the Abbott Molecular Bar Code Scanner User's Guide, List Number 6L88-02/09, the section Modifying the Keyboard Format for Bar Code Scanner LN 6L89-01 contains incorrect bar codes that can prevent the correct configuration of the bar code scanner language format. The Abbott m2000 System is intended for use in performing nucleic acid testing in clinical laboratories. It is comprised of the Ab