FDA Sets 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.
Source: Drug Industry Daily