A customer from the united states had notified biomérieux of false negative results associated with the vidas® lyme igg ii involving a patient sample.An internal biomérieux investigation was performed.The patient sample was not submitted for evaluation.The analysis of batch history records for vidas lyme igg ii lot 1005659490 /180710 0 showed no anomaly during the manufacturing and control processes.The analysis of control charts of eight (8) internal samples, three (3) negative, five (5) positive, on seven (7) vidas lyme igg ii batches (including lot mentioned by customer) showed that all the results were within specifications.Vidas lyme igg ii lot 1005659490 /180710 0 is in the trend of the other batches.The complaint laboratory tested five (5) internal samples (five (5) positive) on a retained kit of vidas lyme igg ii lot 1005659490 /180710 0.The results obtained were within the expected specifications and similar to those obtained during release.There is no drift of vidas lyme igg ii lot 1005659490 /180710 0 since its release.As it was not possible to get the sample, no further investigation could be performed.Vidas lyme igg ii lot 1005659490 /180710 0 performed within the expected specifications.
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