An internal investigation was performed for a misidentification of listeria monocytogenes as several other listeria species or unidentified when tested with the vitek® 2gram-positive (gp) identification (id) card (lot 2420575103) using vitek 2 software version 7.01.The strain was identified as l.Monocytogenes by api, pcr and maldi-tof.Investigation: no set up information was provided.It's not clear if the testing involved one isolate or several.It was noted that the customer had received a new lot of gp cards from a new supplier and experienced issues.However the customer did not perform qc on the new lot of cards from the new supplier.Eight lab reports were submitted.One lab report showed a low discrimination result between l.Monocytogenes and l.Welshimeri.This is considered a correct result.Two lab reports showed an unidentified organism result with five atypical positive reactions (dxyl, dsor, llatk, dman, dgal) for an identification of l.Monocytogenes according to the gp knowledge base.Four lab reports showed an identification of l.Welshimeri.Two lab reports showed one atypical positive reaction (dxyl) and two lab reports showed three atypical reactions (dxyl+, aglu-, dgal+) for an identification of l.Monocytogenes according to the gp knowledge base.One lab report showed an identification of l.Grayii with three atypical positive reactions (dsor, dgal, dman) for an identification of l.Monocytogenes according to the gp knowledge base.Atypical positive reactions can indicate contamination, mixed culture, use of non recommended media or other user set up errors or an atypical strain.However without the strain or raw data it's not possible to further evaluate the cause of the misidentification.The vitek 2 gp lot #2420575103 met final qc release criteria.This lot passed qc performance testing.
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