AdventHealth said it received 35,000 tests from a third-party lab that were found to be unreliable. USA Today identified the lab as MicroGen DX, in Lubbock, Texas.
AdventHealth said MicroGen failed to meet promised turnaround times so it sent a team to the lab and found test samples left at room temperature.
Samples are supposed to be refrigerated at about 32 degrees Fahrenheit and placed in freezers at minus 94 degrees after three days, according to the CDC.
MicroGen CEO Rick Martin told USA Today that the samples were still valid.
FDA investigators are reviewing the data and interviewing experts on the matter, USA Today reported.
Mr. Martin told USA Today that as of May 21, the lab hadn’t been contacted by the FDA, but it plans to cooperate fully if it is investigated. He also said the reason MicroGen failed to meet promised turnaround times was because AdventHealth didn’t provide proper patient data and because the lab ran out of plastic parts needed in its testing material.
Read the full article here.
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