Siemens filed the initial mdr 1219913-2019-00005 on january 23, 2019.02/01/2019 additional information: the customer had high recovery with bio-rad virotrol ii quality control lot 123590 and patient samples when using advia centaur xpt anti-hbs2 (ahb2) lot 098.When the customer switched to the advia centaur xpt anti-hbs2 (ahb2) lot 102, the quality control and patient samples recovered acceptably.Siemens does not have any claims on how bio-rad virotrol ii controls recover lot to lot so the shift in recovery is not a product issue.Internal data and field data from other customers does not show the same bias between the advia centaur xpt anti-hbs2 lot 098 and lot 102 with patient samples that the customer observed.The customer does not know whether the advia centaur xpt anti-hbs2 lot 098 kits that they used were from the same shipment.The root cause of the high recovery the customer observed with the advia centaur xpt anti-hbs2 lot 098 cannot be determined.Siemens cannot rule out a shipping/handling issue with the reagents.Based on the available information advia centaur xpt anti-hbs2 lot 098 is performing as intended.The instrument is performing within specifications.No further evaluation of the device is required.Mdr 1219913-2019-00010 supplemental report 1 was filed for the same event (same customer different site).
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