The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1531-2015·Announced 2015-05-06

Beckman Coulter Recalls MicroScan Microbiology Panels Due to Performance Limitation

Beckman Coulter is recalling MicroScan Microbiology Systems panels because a 2013 bulletin failed to mention a performance limitation 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. The hazard involves a performance limitation in a diagnostic device that could lead to incorrect susceptibility reporting, but no specific injuries or illnesses are reported in the source text, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Beckman Coulter, Inc. is recalling MicroScan Microbiology Systems Dried Gram Negative MIC/Combo Panels, specifically the Neg/Urine Combo 55 panel (Catalog B1017-409). The recall is due to a performance limitation regarding the testing of Proteus mirabilis and Imipenem (Imp) when using the CLSI M100-S20 revised interpretive criteria.

The issue stems from a Technical Support Bulletin issued in February 2013, which did not mention this specific performance limitation. The affected products are designed for use in determining antimicrobial agent susceptibility and identification of aerobic and facultatively anaerobic gram-negative bacilli.

Approximately 216,240 boxes were distributed in the U.S. and 84,249 boxes were distributed outside the U.S. The products were distributed nationwide in the U.S. and to various countries including Argentina, Brazil, Canada, China, Germany, and others. Users should contact Beckman Coulter for further instructions on handling the recalled panels.

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 55, Catalog B1017-409 Microbiology: For use with MicroScan Dried Gram Negative MIC/Combo Panels and…
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: B1017-409
  • Siemens Material Number (SMN): 10371533.

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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