Home › Device types › LON
System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
FDA product code LON · Class 2 · Microbiology
201
Registered devices
3,999
Adverse events
240
Recalls
291
510(k) clearances
Devices with this code
BD Phoenix™ NMIC-300 — BECTON, DICKINSON AND COMPANYBD Phoenix™ NMIC-311 — BECTON, DICKINSON AND COMPANYMicroScan — Beckman Coulter, Inc.BD Phoenix™ AST-S Indicator Solution — BECTON, DICKINSON AND COMPANYVITEK® 2 AST-GN49 — BIOMERIEUX , INC.VITEK® 2 AST-XN31 — BIOMERIEUX , INC.VITEK® 2 COMPACT — BIOMERIEUX , INC.VITEK® 2 AST-GN87 — BIOMERIEUX , INC.VITEK® 2 AST-N811 — BIOMERIEUX , INC.BD Phoenix™ SMIC-101 — BECTON, DICKINSON AND COMPANYVITEK® 2 AST-GN82 — BIOMERIEUX , INC.BD Phoenix™ NMIC-133 — BECTON, DICKINSON AND COMPANYVITEK® 2 AST-N816 — BIOMERIEUX , INC.MicroScan — Beckman Coulter, Inc.BD Phoenix™ AST Broth 4.5 mL — BECTON, DICKINSON AND COMPANYBD Phoenix™ AST Indicator Solution — BECTON, DICKINSON AND COMPANYBD Phoenix™ PMIC/ID-107 — BECTON, DICKINSON AND COMPANYVITEK — BIOMERIEUX , INC.BD Phoenix™ NMIC/ID-132 — BECTON, DICKINSON AND COMPANYDENSICHEK® Plus — BIOMERIEUX , INC.VITEK® 2 AST-XN30 — BIOMERIEUX , INC.BD Phoenix™ SMIC/ID-101 — BECTON, DICKINSON AND COMPANYVITEK® 2 AST-GN74 — BIOMERIEUX , INC.VITEK® 2 AST-N807 — BIOMERIEUX , INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-08-13 | Becton Dickinson & Co. | Potential for quality control failures with Klebsiella pneumoniae ATCC BAA-1705 when using the CPO Ambler classification feature. |
| 2026-08-13 | Becton Dickinson & Co. | Potential for quality control failures with Klebsiella pneumoniae ATCC BAA-1705 when using the CPO Ambler classification feature. |
| 2026-07-24 | Biomerieux Inc | The issue is related to card pouch damage associated with a portion of the lot which was produced on a specific card pouching device, in a specific timeframe, c |
| 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 |
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