Home › Device types › LON
System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
FDA product code LON · Class 2 · Microbiology
196
Registered devices
3,807
Adverse events
237
Recalls
289
510(k) clearances
Devices with this code
BD Phoenix™ PMIC-107 — BECTON, DICKINSON AND COMPANYVITEK® 2 AST-GN48 — BIOMERIEUX , INC.Selux AST Gram Negative Panel — Selux Diagnostics, Inc.MicroScan — Beckman Coulter, Inc.VITEK® 2 AST-XN31 — BIOMERIEUX , INC.BD Phoenix™ AP AST Indicator Solution — BECTON, DICKINSON AND COMPANYVITEK® 2 AST-GN75 — BIOMERIEUX , INC.VITEK® 2 AST-GN93 — BIOMERIEUX , INC.BD Phoenix™ NMIC-123 — BECTON, DICKINSON AND COMPANYVITEK® 2 DENSICHEK® Plus Standards Kit — BIOMERIEUX , INC.BD Phoenix™ NMIC-300 — BECTON, DICKINSON AND COMPANYMicroScan — Beckman Coulter, Inc.VITEK® 2 AST-GN86 — BIOMERIEUX , INC.BD Phoenix™ NMIC/ID-126 — BECTON, DICKINSON AND COMPANYBD Phoenix™ AST Broth 4.5 mL — BECTON, DICKINSON AND COMPANYMicroScan — Beckman Coulter, Inc.VITEK® 2 Pipetter/Diluter Accessories Kit — BIOMERIEUX , INC.MicroScan — Beckman Coulter, Inc.VITEK® 2 AST-GN14 — BIOMERIEUX , INC.BD Phoenix™ PMIC-108 — BECTON, DICKINSON AND COMPANYBD Phoenix™ NMIC-306 — BECTON, DICKINSON AND COMPANYVITEK® 2 COMPACT — BIOMERIEUX , INC.VITEK® 2 AST-GN77 — BIOMERIEUX , INC.VITEK® 2 AST-N806 — BIOMERIEUX , INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-06-26 | Beckman Coulter Inc. | Analyzers contain incorrect algorithms which may affect antimicrobial susceptibility test results, leading to false susceptibility classifications." |
| 2026-06-26 | Beckman Coulter Inc. | Analyzers contain incorrect algorithms which may affect antimicrobial susceptibility test results, leading to false susceptibility classifications." |
| 2026-06-04 | Biomerieux Inc | Potential for false resistant carbapenem and/or cephalosporin results when analyzing samples with kits from affected lot that have pouch foil fractures. |
| 2025-09-23 | Becton Dickinson & Co. | Product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product se |
| 2025-06-26 | bioMerieux, Inc. | Potential for false resistant results for Colistin (cs02n) with multi-drug-resistant Pseudomonas aeruginosa and Acinetobacter baumannii complex used in specific |
| 2024-10-31 | Becton Dickinson & Co. | BD confirmed that product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Unti |
| 2024-08-01 | Becton Dickinson & Co. | Escherichia coli (E. coli) misidentification for clinical samples that were tested on BD Phoenix" M50 instrument and BD Phoenix" 100, may lead to misdiagnosis a |
| 2024-08-01 | Becton Dickinson & Co. | Escherichia coli (E. coli) misidentification for clinical samples that were tested on BD Phoenix" M50 instrument and BD Phoenix" 100, may lead to misdiagnosis a |
| 2024-03-14 | Biomerieux Inc | Ceftriaxone (cro02n) concentration errors associated with specific recently manufactured test kits which would have the potential for for false susceptible resu |
| 2024-02-29 | Becton Dickinson & Co. | Esculin, a substrate used in other panels and normally in A16 well, was found in A17 well. A17 in yeast panels is supposed to be an empty well and is not a part |
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