Response to device evaluated by manufacturer: cartridges used by the consumer were not sent back for evaluation, therefore, the devices could not be evaluated.The customer provided information regarding the suspected false negative tests and a member of the technical support group was able to perform data analysis.The complaint history was reviewed and there were two similar complaints against involved lot.The lot history record (lhr) was reviewed for the lot number in the complaint, and it passed release specifications.Technical operations reproduced the failure mode of false negatives during investigation.From the investigation, the cartridges that generated false negative tests revealed no significant mechanical failures or contributions to the false negative results.Subsequent investigation into the wet reagent buffers and the pellet similarly found inconclusive results.Additional root cause analysis was unable to determine a true root cause for the failures in this cartridge lot.The root cause is undetermined.
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