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AST Analyzer

Selux Diagnostics, Inc. · Model 01-10014 · UDI-DI 00850031114043

LON LTW LTT Prescription

510(k) clearances

3,851

Adverse events (6 deaths)

240

Recalls

Facilities

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, causing a potential r
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 service credentials ar
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 cards
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. Until these product serv
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 and inappropriate tre

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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.