Dr. Robert R. Redfield, the director of the C.D.C., and other health experts have long suggested that contamination in the labs might have been the culprit. But even as several officials at the F.D.A. late this week cited contamination as the cause, a spokesman for the C.D.C., Benjamin Haynes, asserted that it was still just a possibility and that the agency was still awaiting the formal findings of H.H.S.
In a statement, however, he acknowledged that the agency’s quality control measures were insufficient during the coronavirus test development. Since then, he said, “C.D.C. implemented enhanced quality control to address the issue and will be assessing the issue moving forward.”
Initially, the C.D.C. was responsible for creating a coronavirus test that state and local public health agencies could use to diagnose Covid-19 in people, and then isolate them to prevent the spread of the disease.
“It was just tragic,” said Scott Becker, executive director of the Association of Public Health Laboratories. “All that time when we were sitting there waiting, I really felt like, here we were at one of the most critical junctures in public health history, and the biggest tool in our toolbox was missing.”
Mr. Becker said that public health laboratories started receiving the C.D.C. kits on Feb. 7, and by the next day members were already calling him to report that the test was not working accurately. He alerted both the C.D.C. and the F.D.A., which regulates medical devices, including laboratory tests.
“This is consistent with what we said was plausible when we found the problem at the beginning,” Mr. Becker said. “When we found the problem, it seemed to our community that it was a contamination issue that would cause a problem to this extent.”
The F.D.A. concluded that C.D.C. manufacturing issues were to blame and pushed the agency to shift production to an outside firm. That company, I.D.T., accelerated production of the C.D.C. test and says no more issues were reported.