Abbott m2000sp Instrument Software Recall for Data Saving Error
Abbott Molecular is recalling m2000sp Instruments due to a software issue where changes to control or calibrator information are not saved.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a moderate risk. The source text describes a software data-saving error without reporting any specific injuries, illnesses, or deaths, fitting the criteria for a moderate severity score.
Plain-English summary
Abbott Molecular is recalling the m2000sp Instrument, an automated fluid handling system used for sample preparation in nucleic acid testing. The recall involves 215 units in the United States and 693 units distributed internationally.
The recall is due to a software issue where changes made to control or calibrator information on the Sample Extraction Assay Details screen are not saved after a specific series of steps. This defect affects all serial numbers and software versions 1.0 through 5.0.
The product is distributed worldwide, including in the United States and numerous international locations. Users of the m2000sp Instrument should contact Abbott Molecular for further instructions regarding the software issue.
The recalled product
- Product
- Abbott m2000sp Instrument; an automated fluid handling system for performing sample preparation for nucleic acid testing; Abbott Molecular Inc., Des Plaines, IL 60018 USA; Abbott m2000sp Instrument; an automated system for performing sample preparation for nucleic acid testing; A
- Manufacturer
- Abbott Molecular
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- list 09K14
- all serial numbers and all software versions 1.0 - 5.0
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Abbott Molecular
See all →- HighAbbott m2000sp Automated Sample Preparation System Recalled for X-Drive Failure
FDA (Devices) · 2015-01-21
- LowAbbott m2000sp Software Incompatibility Recall for Nucleic Acid Testing
FDA (Devices) · 2014-12-03
- ModerateAbbott 5 mL Reaction Vessels Recalled for Insufficient Rim Defect
FDA (Devices) · 2014-08-20
- ModerateAbbott Molecular Recalls CEP 8 Probe Kits Containing Incorrect Probe
FDA (Devices) · 2014-04-30
- ModerateAbbott Molecular Bar Code Scanner User's Guide Recalled for Incorrect Bar Codes
FDA (Devices) · 2012-07-25
Same hazard · software defect
See all →- HighMidmark IQecg Digital ECG Software Recall for Inaccurate Waveforms
FDA (Devices) · 2026-09-02
- HighMidmark Digital ECG Software Recall for Incorrect Waveform Display
FDA (Devices) · 2026-09-02
- ModerateEndoFLIP System Recall Due to Incorrect Catheter Expiration Flags
FDA (Devices) · 2026-08-26
- HighBeckman Coulter DxC 500i Analyzer Modules Recalled for Software Defect
FDA (Devices) · 2026-08-26
- HighMitsubishi Recalls Outlander Models for Rearview Camera Software Defect
NHTSA · 2026-08-25