Beckman Coulter Recalls MicroScan Panels Due to Performance Limitation
Beckman Coulter is recalling MicroScan Dried Gram Negative MIC/Combo Panels because a technical bulletin omitted a performance limitation for Proteus mirabilis.
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, and the hazard involves a technical performance limitation in a diagnostic device rather than a direct physical injury or acute health threat, fitting the Moderate criteria.
Plain-English summary
Beckman Coulter, Inc. is recalling MicroScan Microbiology Systems Dried Gram Negative MIC/Combo Panels, specifically the Neg/BP Combo 47 panel (Catalog B1017-417). The recall involves approximately 216,240 boxes in the United States and 84,249 boxes outside the U.S.
The recall was initiated because a Technical Support Bulletin issued in February 2013 failed to mention a performance limitation regarding Proteus mirabilis and Imipenem (Imp) when using the CLSI M100-S20 revised interpretive criteria. These panels are used in laboratories to determine antimicrobial susceptibility and identify aerobic and facultatively anaerobic gram-negative bacilli.
The affected products were distributed nationwide in the United States and to various countries worldwide, including Canada, Germany, and China. Users of these products should contact Beckman Coulter for further instructions on how to proceed.
The recalled product
- Product
- MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imipenem Dilutions for Reporting CLSI M100-S20 Breakpoints Panel: Neg/BP Combo 47, Catalog B1017-417 Microbiology: For use with MicroScan Dried Gram Negative MIC/Combo Panels and Dried Gr
- Manufacturer
- Beckman Coulter, Inc.
- 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 (2)
- Catalog number: B1017-417
- Siemens Material Number (SMN): 10483099.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 7 recalled by Beckman Coulter, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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