The FDA has posted 5 enforcement recalls of short incubation antimicrobial susceptibility automated test system devices since 2025, none of them Class I (most serious). Most recent report: Aug 12, 2026.
Analyzers contain incorrect algorithms which may affect antimicrobial susceptibility test results, leading to false susceptibility classifications."
Analyzers contain incorrect algorithms which may affect antimicrobial susceptibility test results, leading to false susceptibility classifications."
Potential for false resistant carbapenem and/or cephalosporin results when analyzing samples with kits from affected lot that have pouch foil fractures.
Product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor.…
Potential for false resistant results for Colistin (cs02n) with multi-drug-resistant Pseudomonas aeruginosa and Acinetobacter baumannii complex used in specific cards
Source: U.S. FDA openFDA device enforcement reports, updated continuously. Device type per the FDA's RES classification (“System, Test, Automated, Antimicrobial Susceptibility, Short Incubation”). Informational only — verify against the FDA before acting.