Complaint investigation confirmed a deficiency where internal control failures due to error code 9186 (internal control failed), for alinity m sars-cov-2 control kit (list 09n78-085) lot 530738, is higher than expected when compared to historical control lot performance.Urgent field safety notice/field correction recall (fa-am-aug2022-279) was issued on august 19, 2022 to address this issue.The field action was reported to the us fda in alignment with the conditions of authorization contained in the associated letter of authorization for the alinity m sars-cov-2 assay eua (list 9n78).This action was communicated to the fda on august 19, 2022.This mdr is being submitted in alignment with the requirements in the letter of authorization of the alinity m sars-cov-2 eua(b)(4), section iv, condition g that abbott molecular will report to fda any suspected occurrence of false positive or false negative results and significant deviations from the established performance characteristics of the product of which we become aware.The following mdrs were also reported as related to fa-am-aug2022-279: 3005248192-2022-00766, 3005248192-2022-00767, 3005248192-2022-00768, 3005248192-2022-00769, 3005248192-2022-00770, 3005248192-2022-00771, 3005248192-2022-00772, 3005248192-2022-00773, 3005248192-2022-00774, 3005248192-2022-00775, 3005248192-2022-00777, 3005248192-2022-00778, 3005248192-2022-00780, 3005248192-2022-00947, 3005248192-2022-00948, 3005248192-2022-00949, 3005248192-2022-00950, 3005248192-2022-00951, 3005248192-2022-00952, 3005248192-2022-00953, 3005248192-2022-00954, 3005248192-2022-00956, 3005248192-2022-00957, 3005248192-2022-00958, 3005248192-2022-00959, 3005248192-2022-00960, 3005248192-2022-00961, 3005248192-2022-00962, 3005248192-2022-00963, 3005248192-2022-00973, 3005248192-2022-00974, 3005248192-2022-00975 and 3005248192-2022-00976.
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