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The Washington State Department of Health has recalled 12,000 coronavirus tests which have been distributed nationwide due to possible contamination after the fluid in several tests was of an unusual color.
Health officials issued the recall Saturday night after UW Medicine, a Seattle-based health care system that purchased the test kits, issued an alert regarding a possible “quality control issue,” said on Sunday ministry in a statement.
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“Although the quality control problem has only been observed in a small number of viral transport medium tubes, we adhere to the highest quality standards for COVID-19 testing in Washington State” said Secretary of Health John Wiesman. “We are working with our partners to get them thrown away and we will work to replace them as soon as possible.”
Viral transport fluid (VTM) is what preserves the specimen during transport. Some vials of VTM were an unusual color and prompted UW Medicine to notify state officials, the department said.
Thousands of test kits have already been sent to local health jurisdictions, tribal nations and partner government agencies across the state when the irregularity was discovered.
Health officials said they believed there was no risk to patient health because the fluid and the patient did not come into contact during a test.
Although tests at UW Medicine determined that quality issues did not affect COVID-19 test results, health officials said they remembered the test kits “for too careful” when of an investigation.
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Due to limited supplies, test kits cannot be replaced immediately, the state health department said, adding that a new shipment is expected this week.
Washington has at least 11,948 confirmed cases of coronavirus and 634 deaths on Monday.
Testing is an important step in determining whether states can loosen the lockdowns that have shut down most businesses and forced residents to stay at home and follow social distancing measures to curb the spread of the virus.
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Nationally, President Trump announced on Sunday evening that the United States had taken a major step in coronavirus testing, telling reporters that 4.18 million Americans have now been screened – more than France, the United – United Kingdom, South Korea, Japan, Singapore, India, Austria, Australia, Sweden and Canada combined.
Gregg Re of Fox News contributed to this report.