Abbott m2000sp Software Incompatibility Recall for Nucleic Acid Testing
Abbott Molecular is recalling m2000sp CD-ROMs because some Application Specifications are incompatible with software versions 6.0 and 7.0, causing error code 9000.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall addresses a software error (Error Code 9000) that prevents specific screen access, which is a functional defect rather than a direct safety hazard involving injury, death, or significant health risk.
Plain-English summary
Abbott Molecular is recalling 9 CD-ROMs in the United States and 1,273 CD-ROMs in foreign countries. These discs contain Application Specifications (App Spec) for the Abbott m2000sp, an automated system used for sample preparation in nucleic acid testing.
The recall is due to a software incompatibility issue. Some versions of the Application Specifications are not compatible with m2000sp system software versions 6.0 and 7.0. When users select the Available Reagent Packs screen, this incompatibility generates Error Code 9000, which indicates an unexpected software error.
The affected products are distributed worldwide, including in the United States (CA, CT, FL, NC, PA, SC, and DC) and numerous other countries. The specific models affected are the E series and G series, identified by List Number 09K14. Users should contact Abbott Molecular for further instructions regarding the replacement or correction of these software components.
The recalled product
- Product
- Abbott m2000sp, an automated system for performing sample preparation for nucleic acid testing.
- Manufacturer
- Abbott Molecular
- Hazard
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 (3)
- List Number: 09K14
- Models: E series
- G series
Distribution
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