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On 22dec2022, grifols customer regionalne centrum krwiodawstwa i krwiolecznictwa w rzeszowie (rckik w rzeszowie, poland) reported a discrepant hbv result between a plasma pool of 4 plasma donors and one of the pool components.The pool of 4 donors was tested on 02dec2022 and was nonreactive (s/co 0.18) with ultrio elite master lot (ml) 704982.It was not tested in the discriminatory assays.The four individual donor components of the pool were tested for serology on 02dec2022 and one sample (z524822006473) was hbsag positive.It was also hbv reactive when tested on 07dec2022 in the artus hbv rg pcr assay.The sample was then tested on 19dec2022 in ultrio elite and was reactive (s/co 11.76).The individual donation with the hbv reactive nat and serology results was blocked from use.An investigation is ongoing for the discrepant result and sample volume is pending return to grifols for hbv quantitation.A review of the quality control data for ultrio elite ml 704982 was performed.There were no related quality events found for this lot/batch of product and the product met all release criteria.Follow-up information for this report will be provided when available.
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On 22dec2022, grifols customer regionalne centrum krwiodawstwa i krwiolecznictwa w rzeszowie (rckik w rzeszowie, poland) reported a discrepant hbv result between a plasma pool of 4 plasma donors and one of the pool components.The pool of 4 donors was tested on (b)(6) 2022 and was nonreactive (s/co 0.18) with ultrio elite master lot: (ml) 704982.It was not tested in the discriminatory assays.The four individual donor components of the pool were tested for serology on (b)(6) 2022 and one sample ((b)(6) was hbsag positive.It was also hbv reactive when tested on (b)(6) 2022 in the artus hbv rg pcr assay.The sample was then tested on (b)(6) 2022 in ultrio elite and was reactive (s/co 11.76).The individual donation with the hbv reactive nat and serology results was blocked from use.An investigation is ongoing for the discrepant result and sample volume is pending return to grifols for hbv quantitation.A review of the quality control data for ultrio elite ml 704982 was performed.There were no related quality events found for this lot/batch of product and the product met all release criteria.Follow-up information for this report will be provided when available.Follow-up: sample (b)(6) was received on 20mar2023.Gds san diego tested it in the aptima hbv quantitative assay on 23mar2023 in two replicates.Both results were <10 iu/ml hbv detected.The sample was originally tested in a pool of four total donors.Based on the hbv quantitation of the positive sample, the approximate titer of that pool would have been <2.5 iu/ml hbv.The 95% detection probability of the ultrio elite assay when testing the hbv who standard (97/750) is 4.3 iu/ml.The root cause of the nonreactive ultrio elite result was low titer sample.Dilution by pooling lowered the concentration of the already low titer sample to a concentration below the limit of detection of the ultrio elite assay.The investigational testing confirmed the ultrio elite assay is working as designed.Procleix ultrio elite assay (mn: 9051171) (lot number: 704982) was manufactured between 8dec2021 and 22apr2022.The master lot has a kit expiration date of 15dec2023.Risk analysis: panther assay specific risk analysis for bloodbank assays, rsk-00854 rev.011 and product safety risk management procedure, 04-03-12-sop version 9.0 were reviewed to assess risk.New risk to patient safety was not identified.There were no related nonconformances noted in the manufacturing record or as part of a search of the nonconformance records for this lot number.Product impact: no impact to product was identified.The root cause of the initial nonreactive was determined to be low titer sample.Review of the investigational testing, qc release data and a previous events search in the grifols complaint system indicate that the assay is working as designed.Customer impact: the impact to the customer was questioning the ultrio elite results and rejecting the donation.Following iso 14971, grifols risk assessment is based on severity of a harm or impact to human health and the probability of occurrence of harm or impact to human health.Based on the severity rating of ·critical· and probability rating of ·remote·, the overall risk posed by a false negative ultrio elite result is determined to be acceptable.This is the final report and no additional information is expected.
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