The initial reporter stated they were having issues with third party control recovery for the elecsys anti-sars-cov-2 assay on a cobas 6000 e 601 module.The issue started when new anti-sars-cov-2 reagent lot 56426000 was placed on board the analyzer on 09-aug-2021.Roche manufactured controls were provided to the customer and these recovered within range on 11-aug-2021.In order to troubleshoot the third party control issue, the customer pulled some patient samples that had been originally tested on (b)(6) 2021 and repeated these after the roche controls were tested on 11-aug-2021.The initial sample values from (b)(6) 2021 were believed to be correct.Of the repeated samples, three samples that were initially non-reactive, now recover with reactive values.No incorrect results were reported outside of the laboratory.The first sample initially resulted in an anti-sars-cov-2 value of 0.312 coi (non-reactive) on (b)(6) 2021.The sample was repeated on (b)(6) 2021, resulting in a value of 1.30 coi (reactive).The second sample initially resulted in an anti-sars-cov-2 value of 0.741 coi (non-reactive) on (b)(6) 2021.The sample was repeated on (b)(6) 2021, resulting in a value of 5.00 coi (reactive).The third sample initially resulted in an anti-sars-cov-2 value of 0.293 coi (non-reactive) on (b)(6) 2021.The sample was repeated on (b)(6) 2021, resulting in a value of 1.52 coi (reactive).The serial number of the e 601 analyzer is (b)(4).
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