[109368487]
A customer from (b)(6) notified biom? Rieux of misidentification results when testing the clostridium sporogenes atcc? 11437? Strain with vitek? 2 anc id test kit (reference 21347). The customer reported testing the isolate three (3) times with the following methods and results: 1- using tsa media and after 24 hours of incubation in anaerobic atmosphere , the customer obtained an identification of slashline (mixed) clostridium group. 2- using cba media and after 24 hours of incubation, still in in anaerobic atmosphere, the customer obtained the same result as slashline clostridium group. 3- using cba media (that is a recommended media for vitek? 2) and after 48 hours of incubation, the customer obtained a low discrimination for clostridium group. The customer reported using an isolated organism from the media where he observed single colonies. This same atcc strain has been identified with the maldi system as c. Sporogenes species. As there is no patient associated with this quality control strain, there is no adverse event related to any patient's state of health. To be noted, as specified in the instructions for use (ref. 043907-02), the impacted atcc 11437 c. Sporogenes strain is not recommended for anc cards. Also the instructions for use (ifu) state the following "certain species may belong to a slashline (mixed) taxa identification. This occurs when the biopattern is the same for the taxa listed. Supplemental tests may be used to separate slashline taxa. " however, vitek 2 provided low discrimination results that did not include clostridium sporogenes. A biom? Rieux internal investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5