Company Pulls Diabetes Test Strips off Market

IRVINE — An Irvine company has voluntarily stopped shipping its diabetes test strips after the Food and Drug Administration determined that the strips didn’t conform to federal standards.

Diagnostic Solutions Inc. withheld the products from the market beginning in December, said Norman Cocke, chief financial officer at Chronimed Inc. in Minneapolis, Diagnostic Solution’s distributor.

The shipment stoppage was revealed by Chronimed on Tuesday in its quarterly earnings announcement. Chronimed sells its own diabetes test strips, along with those made by Diagnostic Solutions, under the name Quick Check.

Diagnostic Solution’s test strips are a generic version of strips made by market leader Johnson & Johnson.

Diabetics use the strips to monitor the level of sugar in their blood. A drop of blood is placed on the strip, which is then placed into a meter that reads the blood sugar content.

Cocke said the FDA, in routine compliance tests, found the Diagnostic Solutions strip “doesn’t conform to standards.”

Diagnostic Solutions voluntarily withdrew the strips “until the matter is cleared up,” he said.

Tests conducted for Diagnostic Solutions and Chronimed show that the strips do conform to FDA standards, Cocke said. Diagnostic Solutions is discussing those results with the agency.

“This should not be viewed as acrimonious at all,” he said. “The object is to resolve it.”

Annual sales of the Diagnostic Solutions test strips are about $10 million, Cocke said. In its earnings report, Chronimed said it has lost about $1 million in revenue since the strips were removed from the market.

Diagnostic Solutions officials could not be reached for comment.