Siemens filed initial mdr 1219913-2022-00392 on nov 16, 2022.Siemens filed mdr 1219913-2022-00392 supplemental 1 on dec 12, 2022.On december 13, 2022 additional information: siemens healthcare diagnostics inc.Investigation confirmed that the failed calibrations are due to the standard s01 value in the master curve card (mcc) for the advia centaur systems lots 19529015 and 27236015, being set at 0.1 index.The s01 value should be 0.01 index.The issue is isolated to the advia centaur systems scovg lots 19529015 and 27236015, smns 1120376 and 1120379.Customers were notified of the issue and instructed to discontinue use of the kits.(us: cc 23-01.A.Us was sent to us customers on 2022-12-16 and outside the us: cc 23-01.A.Ous was sent to customers on 2022-12-16 who have received the advia centaur systems sars-cov-2 igg (scovg) lots 19529015 and 27236015).In section h6, medical device problem code, the type of investigation, investigation finding, and investigation conclusion codes were updated.
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Initial mdr 1219913-2022-00392 was filed on nov 16, 2022 reporting, an outside the united states customer contacted siemens customer care center to report the advia centaur xp sars-cov-2 igg (scovg) assay was unable to be calibrated due to imprecision of the low calibrator.Nov 17, 2022 and nov 30, 2022 additional information: section d8 - was this device serviced by a third party? updated to no.Section e1 - telephone number updated to (b)(6).Siemens continues to investigate.
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