Beckman Coulter Recalls MicroScan Panels Due to Performance 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, and the hazard involves a technical performance limitation in a diagnostic device rather than a direct physical injury or acute health threat, fitting the Moderate criteria.
Plain-English summary
Beckman Coulter, Inc. is recalling MicroScan Microbiology Systems Dried Gram Negative MIC/Combo Panels, specifically the Neg/BP Combo 47 panel (Catalog B1017-417). The recall involves approximately 216,240 boxes in the United States and 84,249 boxes outside the U.S.
The recall was initiated because a Technical Support Bulletin issued in February 2013 failed to mention a performance limitation regarding Proteus mirabilis and Imipenem (Imp) when using the CLSI M100-S20 revised interpretive criteria. These panels are used in laboratories to determine antimicrobial susceptibility and identify aerobic and facultatively anaerobic gram-negative bacilli.
The affected products were distributed nationwide in the United States and to various countries worldwide, including Canada, Germany, and China. Users of these products should contact Beckman Coulter for further instructions on how to proceed.
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/BP Combo 47, Catalog B1017-417 Microbiology: For use with MicroScan Dried Gram Negative MIC/Combo Panels and Dried…
- Manufacturer
- Beckman Coulter, Inc.
- 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: B1017-417
- Siemens Material Number (SMN): 10483099.
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 →Related recalls
Same manufacturer · Beckman Coulter, Inc.
See all →- ModerateBeckman Coulter Recalls DxC 500i Clinical Analyzer Modules Due to Software Error
FDA (Devices) · 2026-10-14
- ModerateBeckman Coulter DxC 500 AU Clinical Chemistry Analyzers Recalled for Software Error
FDA (Devices) · 2026-10-14
- HighBeckman Coulter DxC 500i Analyzer Modules Recalled for Software Defect
FDA (Devices) · 2026-08-26
- HighBeckman Coulter DxC 500 AU Analyzer Software Defect Recall
FDA (Devices) · 2026-08-26
- High
Same hazard · mis labeling
See all →- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-10-14
- SevereBetter Bakehouse Recalls Donutful Chocolate Dipped Vanilla Cake Donuts for Undeclared Milk
FDA (Food) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- ModerateHalyard Laparoscopy Comprehensive Pack II Recalled for Latex Content
FDA (Devices) · 2026-10-14
Similar recalls
- ModerateBeckman Coulter Recalls MicroScan Neg Breakpoint Combo Panel Type 34
FDA (Devices) · 2015-05-06
- HighBeckman Coulter MicroScan Pos Combo Panels Recalled for False Negative Results
FDA (Devices) · 2016-01-06
- ModerateBeckman Coulter Recalls MicroScan Pos Breakpoint Combo Panels Due to False Negatives
FDA (Devices) · 2016-01-06
- SevereBeckman Coulter MicroScan Pos Breakpoint Combo Panel Recall
FDA (Devices) · 2016-01-06
- HighBeckman Coulter MicroScan Pos Combo Panel Recall for False Negatives
FDA (Devices) · 2016-01-06
- HighBeckman Coulter MicroScan Pos Combo Panel Recall for False Negative Results
FDA (Devices) · 2016-01-06