Patient identifier = sid (b)(6).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, list number 6a53 that has a similar product distributed in the us, list number 6e50.There is no further donor information provided due to privacy issues.
|
The customer's attachments were reviewed and showed the complaint issue, but no further issues were identified.Since the lot number which was used for testing was unknown, no lot search could be performed.A review of the tracking and trending determined that there are no trends identified for prism htlv-i/htlv-ii, list number 6a53.A 12-month review of the performance of the prism htlv-i/htlv-ii, ln 6a53, was done and no events or issues that may have impacted the performance of the assay in relation to the complaint issue were identified.Return testing was not completed as returns were not available.Historical performance in the field of prism htlv-i/htlv-ii reagent lots using world wide data through abbottlink was evaluated.The initial reactive (ir) and repeat reactive (rr) rate was compared to the prism htlv-i/htlv-ii package insert specifications (irr: 0.07 % (95% ci: 0.02-0.17%); rrr: 0.06 % (95% ci: 0.02-0.15%); specificity: 99.96 % (95% ci: 99.87-99.99%).Even when assuming a zero prevalence of htlv-i/htlv-ii infection for the tested samples, the specificity of all lot numbers is within package insert specifications.A review of labeling concluded that the issue is sufficiently addressed.Based on the investigation no product deficiency was identified for the prism htlv-i/htlv-ii assay.
|