A customer from outside of the united states observed reproducible calibration failure due to excessive deviation for the low calibrator when using the advia centaur sars-cov-2 igg (scovg) assay.There are no allegations of patient harm, changes in treatment, or diagnostic delays due to the observed calibration failure.Siemens healthcare diagnostics is investigating the observed problem.Although there is no potential for serious injury in this case, an mdr will be reported to the fda as a requirement of the emergency use authorization (eua).
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Mdr 1219913-2022-00391 was initially filed on 2022-11-29.Additional information, 2022-12-13: 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).Note: in section h6, the codes for type of investigation, investigation findings and investigation conclusion have been updated.
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