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BD Phoenix™ NMIC/ID-128

BECTON, DICKINSON AND COMPANY · Model 448728 · UDI-DI 30382904487288

LON Prescription
27
510(k) clearances
3,851
Adverse events (6 deaths)
237
Recalls
23
Facilities

Description

BD Phoenix™ NMIC/ID-128

Recalls

DateFirmReason
2026-06-26Beckman Coulter Inc.Analyzers contain incorrect algorithms which may affect antimicrobial susceptibility test results, leading to false susceptibility classifications."
2026-06-26Beckman Coulter Inc.Analyzers contain incorrect algorithms which may affect antimicrobial susceptibility test results, leading to false susceptibility classifications."
2026-06-04Biomerieux IncPotential for false resistant carbapenem and/or cephalosporin results when analyzing samples with kits from affected lot that have pouch foil fractures.
2025-09-23Becton 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 service credentials ar
2025-06-26bioMerieux, Inc.Potential for false resistant results for Colistin (cs02n) with multi-drug-resistant Pseudomonas aeruginosa and Acinetobacter baumannii complex used in specific cards
2024-10-31Becton 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. Until these product serv
2024-08-01Becton 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 and inappropriate tre
2024-08-01Becton 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 and inappropriate tre
2024-03-14Biomerieux IncCeftriaxone (cro02n) concentration errors associated with specific recently manufactured test kits which would have the potential for for false susceptible results. The risk is pr
2024-02-29Becton 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 of the normal ID ev

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.