Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1532-2015·Announced 2015-05-06

Beckman Coulter Recalls MicroScan Dried Gram Negative MIC Panels

Beckman Coulter is recalling MicroScan Dried Gram Negative MIC/Combo Panels because a technical bulletin failed to mention performance limitations for Proteus mirabilis and Imipenem.

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 temporary or medically reversible adverse health consequence. The hazard is a performance limitation in a diagnostic tool rather than a direct physical injury or contamination, fitting the Moderate severity criteria for labeling or performance errors without reported harm.

Plain-English summary

Beckman Coulter, Inc. is recalling MicroScan Microbiology Systems Dried Gram Negative MIC/Combo Panels, specifically the Neg/Urine Combo 61 panel (Catalog B1017-414). 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 did not mention a performance limitation regarding Proteus mirabilis and Imipenem when using the CLSI M100-S20 revised interpretive criteria. This omission could affect the accuracy of susceptibility reporting for these specific conditions.

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 China. Healthcare facilities and laboratories that use these panels should contact Beckman Coulter for further instructions on handling the affected product.

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 61, Catalog B1017-414 Microbiology: For use with MicroScan Dried Gram Negative MIC/Combo Panels and…
Manufacturer: Beckman Coulter, Inc.
Category: Medical Device — Laboratory Diagnostic
Hazard: performance-limitation
mis-labeling

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: B1017-414
Siemens Material Number (SMN): 10483097.

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.

See all 7 products in this recall →

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