Potential for false resistant results for Colistin (cs02n) with multi-drug-resistant Pseudomonas aeruginosa and Acinetobacter baumannii complex used in specific cards
Biomerieux
376 recalls • • Categories: Diagnostic Equipment, Surgical Instruments, Other Medical Devices, Infusion Pumps, Implants & Prosthetics
Ceftriaxone (cro02n) concentration errors associated with specific recently manufactured test kits which would have the potential for for false susceptible results. The risk is present for isolates that have a result of MIC=0.5, 1, 2.
For users with MYLA V4.8.X / V4.9 that use VITEK MS to identify organisms as part of their workflow, AST filter rules that have been activated are not always being applied to AST results when sending the results to the clinician.
Class I - Dangerous
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Class I - Dangerous
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Class I - Dangerous
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Class I - Dangerous
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Class I - Dangerous
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Class I - Dangerous
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Class I - Dangerous
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Class I - Dangerous
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Class I - Dangerous
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Class I - Dangerous
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Class I - Dangerous
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Class I - Dangerous
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Class I - Dangerous
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Class I - Dangerous
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Class I - Dangerous
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Class I - Dangerous
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Class I - Dangerous
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Class I - Dangerous
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Class I - Dangerous
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Class I - Dangerous
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Class I - Dangerous
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Class I - Dangerous
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Class I - Dangerous
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Class I - Dangerous
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Class I - Dangerous
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Class I - Dangerous
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Class I - Dangerous
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Class I - Dangerous
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Class I - Dangerous
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Class I - Dangerous
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Class I - Dangerous
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Class I - Dangerous
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Class I - Dangerous
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Class I - Dangerous
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Class I - Dangerous
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Class I - Dangerous
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Class I - Dangerous
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Class I - Dangerous
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Class I - Dangerous
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Class I - Dangerous
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Class I - Dangerous
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Class I - Dangerous
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Class I - Dangerous
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Class I - Dangerous
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Class I - Dangerous
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Class I - Dangerous
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Class I - Dangerous
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Class I - Dangerous
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Class I - Dangerous
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Class I - Dangerous
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Class I - Dangerous
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Class I - Dangerous
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Class I - Dangerous
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Class I - Dangerous
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Class I - Dangerous
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Class I - Dangerous
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Class I - Dangerous
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Class I - Dangerous
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Class I - Dangerous
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Class I - Dangerous
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Class I - Dangerous
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Class I - Dangerous
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Class I - Dangerous
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Class I - Dangerous
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Class I - Dangerous
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Class I - Dangerous
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Class I - Dangerous
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Class I - Dangerous
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Class I - Dangerous
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Class I - Dangerous
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Class I - Dangerous
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Class I - Dangerous
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Class I - Dangerous
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Class I - Dangerous
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Class I - Dangerous
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Class I - Dangerous
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Class I - Dangerous
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Class I - Dangerous
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Class I - Dangerous
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Class I - Dangerous
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Class I - Dangerous
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Class I - Dangerous
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Class I - Dangerous
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Class I - Dangerous
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Class I - Dangerous
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Class I - Dangerous
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Class I - Dangerous
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Class I - Dangerous
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Class I - Dangerous
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Class I - Dangerous
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Class I - Dangerous
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Class I - Dangerous
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Class I - Dangerous
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Class I - Dangerous
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Class I - Dangerous
Invalid calibrations (out of range high) while using the product.
Class I - Dangerous
There are 7 reported software anomalies that may affect use of the device.
Class I - Dangerous
There is a potential of no result leading to possible delayed result due to contamination of extraction reagents.