Reason/Issue |
One lot of the BD MAX SARS-CoV-2 assay may produce false negative results due to decreased activity of the enzyme utilised in the manufacture of this assay’s master mix. A review of all products produced with this master mix has been undertaken and no other assays are impacted.
As a result of this problem, there is the potential for erroneous results, that could cause delayed or absent administration of anti-viral treatment in certain populations or increase the risk of unidentified disease progression. False negative results may also elongate unnecessary broad-spectrum empiric antibiotic therapy and diagnostic testing or increase the risk of viral transmission, especially in the case of asymptomatic patients. |