The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1534-2015·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 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. The hazard involves a documentation omission regarding performance limitations, which is a moderate risk of adverse health consequences due to potential misinterpretation of test results, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

Beckman Coulter, Inc. is recalling MicroScan Microbiology Systems Dried Gram Negative MIC/Combo Panels containing lower imipenem dilutions for reporting CLSI M100-S20 breakpoints. The specific product affected is the ESBL plus panel, catalog number B1027-101, and Siemens Material Number 10444755. The recall involves approximately 216,240 boxes in the U.S. and 84,249 boxes outside the U.S.

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.

The products were distributed worldwide, including nationwide in the United States and in countries such as Argentina, Brazil, Canada, China, Germany, and Mexico. Users of these panels should contact Beckman Coulter for further instructions regarding the recall and replacement of the affected units.

The recalled product

Product
MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imipenem Dilutions for Reporting CLSI M100-S20 Breakpoints Panel: ES¿L plus, Catalog B1027-101 Microbiology: For use with MicroScan Dried Gram Negative MIC/Combo Panels and Dried Gram…
Manufacturer
Beckman Coulter, Inc.
Category
Medical Device — In Vitro Diagnostics
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: B1027-101
  • Siemens Material Number (SMN): 10444755.

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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