(b)(6) hospital uses one cepheid and 3 diasorin liaison mdx covid-19 testing instruments in our laboratory.A trend was noted over the weekend where we had an abnormally high number of covid-19 positive tests.We initiated a root cause analysis of the situation and it revealed the following.All three diasorin instruments were contaminated with covid-19 following manufacturer cleaning guidelines.We contacted the manufacturer and deep cleaned all three instruments at least a dozen times and the machines continued to remain contaminated with covid-19.The company is sending a field scientist to inspect, decontaminate and re-certify individual instruments on (b)(6) 2021.Manufacturer aware, hospital working to mitigate situation.Currently not using any of the contaminated machines.Fda safety report ids # (b)(4).
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