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 (b)(6) 2022.This mdr is being submitted in alignment with the requirements in the letter of authorization of the alinity m sars-cov-2 eua200572, 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.
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The complaint investigation determined a product deficiency for alinity m sars-cov-2 control kit (list: 09n78-085) lot: 530738.Complaint ticket documents 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.Alinity m sars-cov-2 ctrl kit part 09n78-085 contains a positive control (pc) and a negative control (nc).One replicate each of the positive and negative control must be valid for the run to be valid.Error code 9186 (internal control failed) invalidates the control sample, and therefore invalidates the run if there is no other valid control.The system will not schedule any new tests when the qc status is invalid.There is no impact to patient samples as the samples are processed independently of the negative control/positive control.There is no potential for incorrect results.This issue may potentially cause a delay in results.
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