An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.This report is being filed on an international product, list number 8d06-39 that has a similar product distributed in the us, list number 8d06-31.There is no further donor information provided due to privacy issues.
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The customer reported (b)(6) architect syphilis results on one female donor unit with several lots.The results provided were: on (b)(6) 2018 initial test with architect lot 83336li00 = (b)(6); repeat testing in duplicate with lot 86129li00 = (b)(6); and the sample was (b)(6) for (b)(6).This sample was retested at (b)(6) university, (b)(6) lab, with the (b)(6).The sample was tested again at the customer site with lot 86151li00 and was (b)(6).The donor unit was not designated for further use.On (b)(6) 2018 the (b)(6); the (b)(6); and the architect = (b)(6).The donor had a known (b)(6) 10 years ago which was not indicated at the time of donation.There was no reported impact to donor/patient management.
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A review of tickets determined that there is no increase in complaint activity for the architect syphilis lots and there are no trends identified for this issue.The returned sample was tested with the following lots: 86129li00 = 0.78 s/co; 83336li00 = 0.81s/co; 86151li00 = 0.82 s/co; and 84076li00 =0.78 s/co which are all nonreactive.The sample was also tested with recomline treponema igg and igm, both showing borderline results.The inno-lia syphilis score showed a positive result for the sample.Sensitivity testing was performed with retained kits of architect syphilis tp reagent, 86151li00 and 84076li00 (as representative lot numbers of each size code 8d06-39 and 8d06-42) and one commercially available seroconversion panel (seracare pss901).The seroconversion panel results were compared with historical data from seracare generated with architect syphilis tp and the reagents detected the same first reactive bleed with comparable s/co values.Additionally, 11 replicates of panel d3 were tested and all values met specifications.The results were in the typical range with no false nonreactive results being obtained.All generated data demonstrates that the performance of the architect syphilis tp reagents 8d06-39, lot numbers 86129li00, 83336li00, 86151li00 and 8d06-42, lot number 84076li00, are not compromised.Manufacturing documentation of lots 86129li00, 83336li00, 86151li00, and 84076li00, has been reviewed and no contributing factors to the complaint could be identified.A review of labeling concluded that the issue is sufficiently addressed.Based on our investigation we have concluded that there is no product deficiency with the architect syphilis tp reagent, lot numbers 83336li00, 84076li00, 86151li00 and 86129li00.
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