FDA Identifies Two Class I Recalls for SonarMed Airway Monitors, One for BioMérieux Test Kits

SonarMed Airway monitors and sensors saw two separate Class I recalls for a restricted inner diameter in the airway and software that failed to detect the partial obstruction, while BioMérieux saw a Class I recall for an antibiotic sensitivity test kit that could produce inaccurate results.

The SonarMed airway monitoring system is intended for use by trained medical professionals to support the management of artificial airways in hospital settings such as intensive care units, operating rooms, emergency departments, and during intrahospital transport.

BioMérieux is recalling their VITEK 2 AST cards — a kit that tests the sensitivity of bacteria to antibiotic — due to a higher concentration of ceftriaxone antibiotic in two wells.

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