Beckman Coulter Recalls MicroScan LabPro Software Due to Editing Error
Beckman Coulter is recalling MicroScan LabPro software because it allows incorrect manual editing of carbohydrate substrates for specific test panels.
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 2/5 (Moderate).
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 situation where use of the product may cause temporary or medically reversible health consequences. No specific injuries or illnesses are reported in the source text, and the issue is a software logic error rather than a direct physical hazard.
Plain-English summary
Beckman Coulter Inc. is recalling the MicroScan LabPro Information Manager System, software versions 1.0 to 4.41. The recall involves 2,702 units total, including 1,032 units in the United States. The software is a Microsoft Windows-based program intended to manage microbial identification and antimicrobial agent susceptibility testing data for trained laboratory personnel.
The recall is being conducted because the software incorrectly allows the operator to manually edit carbohydrate substrates when manually reading dried overnight gram-negative panels with an ID Hold status. This defect could potentially affect the accuracy of the data management system.
The affected software was distributed to various countries, including the United States, Canada, Japan, and several European and South American nations. Laboratory personnel using this software should contact Beckman Coulter for further instructions on how to address the issue.
The recalled product
- Product
- MicroScan LabPro Information Manager System, Software Versions 1.0 to 4.41 Catalog No. 10638819, 10638820, 10638823, 10638824, 10638825,10638826, 10714149,10714159, 10805072, 10805073, 10975000, 10975001, 6000-0008, 6000-0026. Japan: 10638819 LabPro v4.11 Software Update…
- Manufacturer
- Beckman Coulter Inc.
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 (1)
- not applicable
Distribution
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