[95850213]
Two customers from (b)(6) notified biom? Rieux of a performance problem with multiple previ? Color reagents when performing gram staining with the previ? Color gram instrument (ref. 414292). The two customers reported observing the same issue, obtaining red stains instead of blue, while working with the same reagent lots but with different models of previ? Color. The strains impacted were streptococcus equi atcc, streptococcus pyogenes in broth with an incubation of four hours, escherichia coli and staphylococcus aureus from broth with an incubation of 24 hours; clinical samples were from plates of blood agar and from bact/alert? Culture bottles. Previ? Color reagents involved: safranin: lot g16717 - ref. 29520 - ((b)(4)), iodine: lot g05515 - ref. 29523 - ((b)(4)), iodine: lot g05615 - ref. 29523 - ((b)(4)), iodine: lot g59407 - ref. 29523 - ((b)(4)), crystal violet: lot g52306 - ref. 29524 - ((b)(4)), crystal violet: lot g07216 - ref. 29524 - ((b)(4)). The two customers were (b)(6) (previ? Color v1, serial number (b)(4)) and (b)(6) (previ? Color v2). One customer changed the programming in the equipment; but the result was the same. (b)(6) tested the instrument with a different lot number of iodine and crystal violet, and the problem was corrected. The customers stated that there were no incorrect results reported, but it took more than 24 hours to cultivate the strains, complete retesting with vitek? And report the results. There is no indication or report from the hospitals or treating physicians to biom? Rieux that the discrepant result led to any adverse event related to any patient's state of health. The customer submitted pictures of the affected slides to biom? Rieux, and the slides were determined to be over-decolorized. A biom? Rieux internal investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5