Beckman Coulter MicroScan Panels Recalled for Missing Proteus Limitation
Beckman Coulter is recalling MicroScan Dried Gram Negative MIC/Combo Panels because a technical bulletin omitted a performance limitation 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, but the source text describes a documentation omission regarding a performance limitation rather than a direct physical hazard or reported injury, fitting the criteria for a moderate severity labeling/documentation issue.
Plain-English summary
Beckman Coulter, Inc. is recalling MicroScan Microbiology Systems Dried Gram Negative MIC/Combo Panels, specifically the Neg/Urine Combo 51 (Catalog B1017-407). These panels are used in laboratories to determine antimicrobial agent susceptibility and identify aerobic and facultatively anaerobic gram-negative bacilli.
The recall was initiated because a Technical Support Bulletin issued in February 2013 failed to mention a performance limitation regarding the use of Proteus mirabilis and Imipenem (Imp) when applying the CLSI M100-S20 revised interpretive criteria. This omission could affect the accuracy of susceptibility reporting for this specific organism and antibiotic combination.
Approximately 216,240 boxes were distributed in the United States and 84,249 boxes were distributed outside the U.S. to various countries including Canada, Germany, and Brazil. Healthcare facilities and laboratories that use these panels should stop using the affected catalog number and contact Beckman Coulter for further instructions.
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/Urine Combo 51, Catalog B1017-407 Microbiology: For use with MicroScan Dried Gram Negative MIC/Combo Panels and…
- 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: B1017-407
- Siemens Material Number (SMN): 110444701.
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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