(b)(4).Upon further inspection, lower volumes of the labiase enzyme were observed in well 2 of the utility tray, as shown in figure 1 (attached).One of the trays had a visibly lower volume of reagent in well 2, compared to the product specification of 100±10 microliters.Nc-04966 and hra-23-0033 were initiated for the nonconforming material.There were no false results observed during final product testing for lot 062123018c.The labiase enzyme in the verigene bc-gp assay is an enzyme preparation useful for the lysis of enterococcus bacteria.Within nc-04966, it was determined that low volumes of the labiase enzyme could result in false-negative results, impacting e.Faecalis, e.Faecium, vana, and vanb.
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It was determined that low volumes of the labiase enzyme could result in false-negative results, impacting e.Faecalis, e.Faecium, vana, and vanb.Per cra-13010, a single false negative efc/efl due to device malfunction or misuse would be reportable as a "serious injury." in general, enterococci are more likely to be resistant to beta-lactams and first-line antimicrobials than staph infections and more likely to be resistant to vancomycin than other bacterial species.Moreover, false negative efl/efc would preclude determination of vana or vanb mediated resistance.As such, the risk to health is greater because inadequate treatment is more likely if vre cannot be identified, and clinicians would likely not administer newer antibiotics such as such as linezolid, quinupristin/dalfopristin, daptomycin, telavancin, dalbavancin, and tigecycline.
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