All available patient information was included.Additional patient details are not available.An evaluation is in process.A final report will be submitted when the evaluation is complete.This report is being filed on an international product, alinity havab igg, list 8p26, that has a similar product distributed in the us, architect havab-g, list number 6l27.This event was previously submitted under an additional suspect medical device in manufacter's report 3002809144-2019-00266.
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A search for similar complaints for the alinity i havab igg, lot number 92507li00 & 93196li00 (the two lots in use by the customer) did not identify additional complaints and no trends were identified for the product issue.Return testing was not completed as returns were not available.92507li00 was expired, therefore, specificity testing was performed using a retained kit of 93196li00.To evaluate reagent specificity, 12 replicates of negative control were tested.All control values met specifications.A review of the manufacturing documentation did not identify any issues associated with the customer's observation.Review of the product labeling concluded that the issue is sufficiently addressed.Based on the investigation, no systemic issue and/or product deficiency was identified.
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