(Reuters) - Atossa Genetics Inc said it would recall a medical device used to collect breast fluid for cancer detection along with a test that uses it, seven months after the U.S. Food and Drug Administration said the device needed additional clearance.
Atossa, whose shares fell 46 percent in extended trading, said the MASCT system and the ForeCYTE test may produce false results.
The FDA’s warning letter on February 21 said the system required additional clearance as changes were made to the collection process after its approval.
Chief Executive Steven Quay said Atossa would submit a new premarket application by the end of the month covering the collection, preparation and processing of breast fluid specimens.
“We would like to have a presubmission meeting (with the FDA) before filing. Unfortunately, the government shutdown makes the timing of the meeting and the subsequent filing impossible to predict,” he said on a conference call with analysts.
Atossa, which signed a deal with U.S. drug wholesaler Mckesson Corp last month to distribute the device, said it would remove the products from the market until the regulator’s concerns were addressed but did not say when it would begin selling them again.
Quay said the company would contact distributors of the device and test over the course of next week.
The company said it was not aware of adverse incidents or injuries occurring as a result of using the device or the test.
Atossa’s shares closed at $5.32 on Friday on the Nasdaq.
Reporting By Vrinda Manocha in Bangalore; Editing by Don Sebastian