ALINITY M SARS AMP KIT (2021-09-07) — recall 62837
Health Canada — Medical Devices · Canada · 2021-09-17 · Type II
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Reported risk: Abbott Molecular inc. Has received reports of Alinity M SARS-CoV-2 EUA false positive results. Preliminary investigation has identified that potential carryover in the assay tray may contribute to false positive results. An evaluation of the current mixing protocol used during preparation of the PCR reaction mixture determined the current mixing parameters may result in potential overflow that could carry over into neighboring wells in the assay reagent tray. Because the assay parameters and the presence of the SARS-CoV-2 analyte are similar, Alinity M Resp-4-Plex customers are being included in this communication.
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