The investigation determined that a false reactive vitros cov2tot result was obtained when a level 1 cov2tot qc fluid was processed using vitros cov2tot reagent lot 0380 on a vitros eci immunodiagnostic system.A definitive cause of the event was not established.The event occurred as part of an internal vitros cov2tot lot 0100 qc post-expiry stability test event.A possible cause of the issue is the cov2tot lot 0100 qc fluid which had expired prior to testing.However, additional cov2tot results obtained during the same post-expiry qc fluid test event were acceptable.A vitros cov2tot reagent lot 0380 reagent issue is an unlikely contributor to the event, as the remaining results from vitros cov2tot lot 0100 qc fluid testing were acceptable.Additionally, ongoing tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with vitros cov2tot lot 0380.An instrument issue cannot be ruled out as a contributor to the event, as no testing was undertaken to confirm the performance of the instrument.Additionally, the false reactive result was isolated to one instrument and additional qc results obtained from three different instruments were all acceptable.It is possible qc fluid mix up occurred, with the vitros cov2tot lot 0100 level 2 (reactive) fluid run in error instead of the non-reactive level 1 qc fluid, however, this could not be confirmed.Qc fluid material contamination cannot be ruled out as a contributor to the event.It was not determined if all testing conducted on (b)(6)2021 was from the same qc fluid bottle/aliquot.Acceptable results were obtained when fresh qc material was used as part of repeat testing on 29 march 2021.Email address for contact office is (b)(6).
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