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Diagnostic Solutions Runs Afoul of FDA

Medicine: For second time, agency says Irvine company's blood-sugar test strips don't conform to federal standards.


IRVINE — Shipments of blood-sugar monitoring strips made by an Irvine company were voluntarily halted for the second time in three months after the firm failed to resolve questions raised by the Food and Drug Administration regarding manufacturing quality.

Diagnostic Solutions Inc. first stopped shipping its strips in December after an FDA test found they didn't conform to federal standards. The company's distributor, Chronimed Inc. in Minneapolis, said at the time that the firms were working to resolve the matter. It resumed shipping the strips earlier this month.

But on Monday, Chronimed said it was suspending shipments of the test strips again and that it might buy the rights to make the products from Diagnostic Solutions.

"We are extremely disappointed to find that the matters that we believed to be settled are not," said Maurice R. Taylor II, Chronimed's president and chief executive.

Taylor said that Chronimed was "taking action to gain control" of the test strip manufacturing process. He said the company would prefer to acquire the rights to make the strips from Diagnostic Solutions and relocate production to an existing Chronimed facility, a move that could disrupt manufacturing for six months to a year. If no deal can be reached, Chronimed might sever its relationship with Diagnostic Solutions, he said.

Officials at the FDA would not comment on how the strips failed to meet federal standards. Executives at privately held Diagnostic Solutions also declined to comment.

The company's test strips, a generic version of a product made by market leader Johnson & Johnson, are sold under the brand name Quick Check. Diabetics use the strips to monitor the level of sugar in their blood.

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