‘Global Home Virus Lab’ issuing recall for millions of test kits

By Cagdas Grisku and Fatma Karasiglu (CNN) — Global Home Virus Lab , a U.S. company that makes home test kits for the non-trivial ones, is recalling about 2 million kits following allegations that…

'Global Home Virus Lab' issuing recall for millions of test kits

By Cagdas Grisku and Fatma Karasiglu (CNN) — Global Home Virus Lab , a U.S. company that makes home test kits for the non-trivial ones, is recalling about 2 million kits following allegations that some of them contain false positives.

The discovery comes as the American Home Test Kit Association was winding down for a week. But by Friday evening, Secretary Timothy Cardinal Dolan sent a letter to the organization urging it to immediately resume operations.

“Due to reports of inaccurate results in a small percentage of global home tests, it has been reported that a small percentage of home kits may have been used improperly,” read a statement from Dolan. “While these kits were in any case detected only harmless microbes, they can nonetheless cause serious alarm to those who use them for research and possible screening purposes.”

The news comes as the company has been experiencing troubles of its own. Under the spotlight of the Food and Drug Administration, the company has been finding trouble.

On Friday, two pharmaceutical companies issued a recall because of found issues with the disinfectant ingredient called MSK. One of the companies, Tekla, recalled about 3,600 kits in the United States and Canada. The other, Bio-Gen Laboratories, had sent out around 1,000 kits, according to FDA reports.

The source of the problem came from a supplier in Canada.

Global Home’s chemical technician who works at a Colorado lab last week discovered a flaw in the process to disinfect the efficacy solution, according to a statement from the company.

“He discovered that the wash cycle was actually allowing infectious bacteria to build up in a way that would be sensitive to the ingredient, Heparin,” the statement read.

“The technician retested the contamination sample and, upon further testing, found that the result was actually a false positive. Other research groups subsequently found similar findings in other Global Home products.”

In a news release, the company said that Global Home has issued a recall of the product and plans to launch a new version of the product that removes the problem.

In a statement, the company said it will take the necessary steps to replace any customers affected by the recall. They offered free tests to customers who had purchased the affected product between March 2018 and October 2018.

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