Beckman Coulter MicroScan Panels Recalled for Missing Proteus Performance Warning
Beckman Coulter is recalling MicroScan Dried Gram Negative MIC/Combo Panels because a technical bulletin failed to mention performance limitations for Proteus mirabilis.
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 adverse health consequences. The specific issue is a missing warning about performance limitations, which fits the criteria for moderate severity.
Plain-English summary
Beckman Coulter, Inc. is recalling MicroScan Microbiology Systems Dried Gram Negative MIC/Combo Panels, specifically the Neg Combo 50 panel (Catalog B1017-406). The recall involves approximately 216,240 boxes in the U.S. and 84,249 boxes outside the U.S., distributed worldwide to numerous countries including Canada, Germany, and China.
The recall was initiated because a Technical Support Bulletin issued in February 2013 did not mention a performance limitation for Proteus mirabilis and Imipenem (Imp) when using the CLSI M100-S20 revised interpretive criteria. These panels are designed for use in determining antimicrobial agent susceptibility and identification of aerobic and facultatively anaerobic gram-negative bacilli.
Healthcare facilities and laboratories that have received these panels should contact Beckman Coulter for instructions on how to handle the affected products. The recall is classified as Class II by the FDA.
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 Combo 50, Catalog B1017-406 Microbiology: For use with MicroScan Dried Gram Negative MIC/Combo Panels and Dried Gram…
- 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 (2)
- Catalog number: B1017-406
- Siemens Material Number (SMN): 10444700
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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