Mueller Hinton E Agar 에 대한 현장 안전성 서한

Field Safety Notice

Slovenia

AMPMDRS

Following qc failures (diameter out of range - too high) when testing atcc strains for antibiotic susceptibility test by disk diffusion method when using mhe agar reported from the field, biomérieux initiated a complaint investigation to check product performance and determine the root cause of the issue observed by a customer. it could be determined that the use of the medium mhe by disk diffusion method with the antibiotics belonging to cyclines and aminosides classes could potentially lead to failure to quality control test (out of range high) and false susceptible result for clinical isolates (whatever the strain that could be tested) instead of resistant results. the investigation states that the identified non-conformity concerns all lots manufactured using a specific formulation. as a consequence new lots produced using new formulations perform within the expected specifications and those new lots are not affected by the above issue. .