A customer from the united states had notified biomérieux of false negative results associated with the vidas® lyme igm involving a patient sample.An internal biomérieux investigation was performed.The patient sample was not submitted for evaluation.The analysis of the batch history records for vidas lyme igm ii lot 1005662400 /180708 0 showed no anomaly during the manufacturing and control processes.The analysis of control charts of eight (8) internal samples, one (1) negative, two (2) equivocal, five (5) positive, on eight (8) vidas lyme igm ii batches (including the lot mentioned by the customer) showed that all the results were within specifications.Vidas lyme igm ii lot 1005662400 /180708 0 is in the trend of the other batches.The complaint laboratory tested five internal samples, four (4) positive and one (1) negative, on a retain kit of vidas lyme igm ii lot 1005662400 /180708 0.The results obtained were within the expected specifications and similar to those obtained during release.There is no drift of vidas lyme igm ii lot 1005662400 /180708 0 since its release.As it was not possible to get the sample, no further investigation could be performed.Vidas lyme igm ii lot 1005662400 /180708 0 performed within the expected specifications.
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