H6: investigation summary: bd was unable to reproduce the customer¿s experience with the bactec product based on our internal procedures and the intended use of the product.Retention samples were visually inspected, tested for viable contamination by sub-culturing on tsa, chocolate, sabouraud and schaedler agars plates, voltage output and gram stain.All results were satisfactory.Batch history record review did not identify any evidence for which the customer submitted the complaint.Bd bactec system is designed and cleared for the qualitative culture and recovery of anaerobic/aerobic organisms from blood.Bd has no specification for use with molecular testing such as the biofire filmarray® blood culture identification bdic/bcid2 panels.While bd highlights the inherent risk of nonviable organisms in blood culture media in our package insert is stated the molecular tests performed on positive blood cultures will detect both viable and non-viable organisms commonly found in culture media.Therefore, molecular test results should be evaluated in conjunction with gram stain results in accordance with standard-of-care practices as well as manufactures¿ instructions for use.Although bd is unable to confirm the complaint, we have initiated capa # 2631844 to further investigate these reports and determine any appropriate actions to reduce their occurrence.A cross functional team continually monitors all product complaints for trends and determines if any additional actions are necessary beyond the current investigational process.H3 other text : see h10.
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